Intraocular Lens Materials & Manufacturing Technology 2013

Transcription

1 Intraocular Lens Materials & Manufacturing Technology 2013

2 Cryo Blocking HF-2 Universal Blanks can be Cryo Blocked by hand using a Benz Table Top freezing device and cryo mandrel or Blocked Optically using the Benz Optical Cryo Blocker. Hand blocking achieves a concentric accuracy of approximately 40 microns. Optical Blocking achieves a concentric accuracy of <10 microns. Benz Blocking Water mixture is used for blocking in both methods. Cryo Machining Machining the Cryo Blocked HF-2 Universal blank is a two pass process carried out at a -28 C surface temperature with -31 C blow off air. The machining parameters are the same as HF-1.2, P 15. THE NEXT GENERATION HYDROPHOBIC MATERIAL HF-2 Preloaded MICS HF-2 is the newest material from Benz, and has been designed as part of a two hydrophobic material strategy. HF-2 is designed for MICS injectors and fast opening times of under 10 seconds. HF-1.2 is designed for mm injectors and has an opening time of 25 seconds (HF-1.2 is discussed in detail on pages 10 11). Both materials are available in the Universal Blank format that greatly reduces the cost of manufacturing hydrophobic IOLs. HF-2 is intended for high value markets that require preloaded MICS capable designs and fast opening times. Lenses made from HF-2 are dry sterilized in plasma or ethylene oxide and do not require wet packaging to achieve both non-stickiness and very low glistenings that are well below the clinical threshold. HF-2 is a unique hydrophobic acrylic polymer that achieves these very advantageous characteristics while maintaining an Abbey number of 47, becoming the first MICS capable hydrophobic material with low chromatic aberration. HF-2 Natural Yellow IOLs have the same Abbey number (47) AND the same transmission spectrum as the young Human Crystalline Lens. The spectral characteristics of HF-2 Natural Yellow IOLs provide the cataract patient with visual characteristics that are the closest yet to the young Human Crystalline Lens. Cryo Milling HF-2 can be cryo milled using either the Benz Peltier Cryo Mill or a MLC (mill/lathe combo), DAC or Optoform, fitted with a Benz Vortex cooling device. The use of an MLC is a one stop process of machining and milling. Using a separate Cryo Mill requires cleaning the Universal Blank after machining and re-freezing it on the Peltier plate of the mill. The milling parameters are the same as HF-1.2, p. 15. HF-2 SPECIFIFATIONS Benz HF-2 Natural Yellow Sterilization HF-2 lenses can be Ethylene Oxide sterilized as is typical for dry sterilized hydrophobic IOLs. Recently, Benz has successfully sterilized both HF-1.2 and HF-2 by H 2 O 2 Plasma. This new method is safe, efficient and has a convenient with cycle time of approximately 50 minutes. Benz HF-2 UVX Water Content; Wt% < 5% < 5% UV Cut Off (1mm disc) < 400nm < 370nm Residuals; % < 0.15% < 0.15% Optic Purity >99.98% >99.98% Severity Index < 750 < 750 Refractive Index at 589nm At 20 C At 20 C (Nominal Value) At 35 C At 35 C Refractive Index at 546nm At 20 C At 20 C (Nominal Value) At 35 C At 35 C ABBE Number Tg 10 C 10 C Opening 25 C* 10 sec 10 sec *Opening Times based on a +27 D C-Loop with a 6.0 mm optic using a 2.2 mm Medicel Accuject Injector Dimension Specifications for HF-2 Universal blanks are on page 10.

3 Introduction to Benz IOL Materials & Manufacturing Technology By Dr. Patrick H. Benz, president Since entering the IOL materials market in 1998, Benz Research and Development has become the preeminent supplier of quality high performance materials and state of the art technology to the IOL industry. The reason for our strong growth is our dedication to excellence in both Quality and Innovation. Our 26 years experience in producing high quality materials for the soft contact lens industry also provides a very significant foundation for hydrophilic IOL materials. Expertise in high purity 2-HEMA monomer production extends over 27 years of continuous development. Our hydrophilic polymer experience of 22 years is substantial. In conjunction with producing 15 novel polymer materials, we have 19 US patents and 14 foreign patents. Combining this level of expertise in developing new materials, it is apparent why we have quickly become the leader in IOL materials and we continue our innovation with 9 US patents pending and 16 foreign patents pending. Our current product line consists of three hydrophilic IOL materials (IOL25 Universal Blank, IOL25, BenzFlex 26) and two hydrophobic IOL materials (HF-1.2 Universal Blank and HF-2 Universal Blank). All of these materials are available with our patented, covalently bound, natural chromophore, Natural Yellow. In creating patented, value added materials, we provide our customers opportunities for significant market differentiation, including increased value to the surgeon as well as the patient. IOL Manufacturing Technologies Developed by Benz Micron run-out Spindle Collets Optical Blocking Optical Cryo Blocking Peltier Effect Cryo Milling Automated IOL Micro Drill Integrated Lens Manufacturing (ILM-3), full automation Fully automated IOL25 Universal Blank Manufacturing (UBM) Fully automated Cryo Manufacturing (ILM-C) Since 1995 Benz Research and Development has committed many man-years of effort to advance the state-of-the art in lens manufacturing technology. Our efforts have yielded both innovative and powerful manufacturing technologies for today s IOL manufacturer. These advances include Optical Blocking, Laser Blocking, Automated Video Inspection, Optical Cryo Blocking, Automated Laser Profiling of Aspheric Optics, a fully Integrated Hydrophilic IOL Manufacturing System and our newest Automated Cryo Manufacturing, all validated to the ISO standard. Our newest material products are the HF-1.2 Universal Blank, HF-2 Universal Blank and the IOL25 Universal Blank. These unique products greatly reduce the manufacturing costs while increasing the precision of IOL manufacture. With our commitment to R&D, we continue to expand the boundaries of both IOL materials and manufacturing technology. Developing superior technology to make superior products this is what Benz Research and Development is all about.

4 Calcium Particle Formation COO - + Ca +2 HPO 4-2 +H 3 O + COO - Ca +2 H 2 PO H 2 O ZERO TECHNOLOGY & ULTRAPURE MONOMER Calcium Phosphate Methacrylic Acid In The Polymer Matrix Calcium Phosphate Particle monomer 99.9% 2 3 Figure 1 Polymer Matrix Polymer Matrix Most manufacturers would agree that high quality products start with high quality raw materials. To the IOL manufacturer, this means the highest quality polymer blanks. For Benz Research and Development this means starting with the very highest Quality monomer raw material possible, period and controlling that quality. Fortunately, we have a vast amount of expertise in the manufacture of high purity 2-Hydroxyethylmethacrylate (2-HEMA), the primary monomer component used in hydrophilic acrylic IOL material. In the mid-1980s we developed a 2-HEMA manufacturing process that produced 99.5% pure monomer, a bench mark for the soft lens industry world wide for more than 19 years. Therefore, we have core expertise in a technology vital to Quality IOL materials. Six years ago, one of our goals as a company was to develop an advanced 2-HEMA manufacturing process that produces raw material monomer with a purity that is consistent with the requirements of the IOL industry rather than the soft lens industry. We call this process Zero Technology. Our Zero Technology Process delivers an ultra pure material with 99.9% purity, the quality expected for a polymer implant that may be in the eye for more than 40 years. We call our IOL monomer, L3 Monomer, for Log 3 or This technology advancement makes Benz R&D the only IOL material supplier that has actual control of its raw material quality and separates us from our competitors, who continue to use raw materials manufactured to meet molded soft lens requirements, not IOL material requirements. We are the only IOL material supplier that is basic in its 2-HEMA monomer raw material. Zero Technology produces a raw material that is so pure that the methacrylic acid content is difficult to even measure. The resulting hydrophilic acrylic IOL polymer has 10 to 20X less acid than even highest purity commercial monomer, plus a much higher total purity, this results in a zero ionicity polymer. Zero ionicity IOL material provides a further degree of Quality Assurance by eliminating the possibility of calcium phosphate particles appearing over time in the polymer matrix, which can lead to opacification, see Figure 1.

5 Residuals Comparison Matrix Size Comparison Competition 1.2 Residuals BENEFITS OF BENZ POLYMERIZATION TECHNOLOGY Percent Residuals (%) Relative Diffusion Rate BenzFlex 26 Competitor BenzFlex 26 Competitor Unbound UV-Blocker residual from alcohol extraction of a hydrophilic IOL material (26% water) from Competitor material. 5 Figure 2 Figure 3 Figure 4 The reputation of Benz Research and Development as a manufacturer of very high quality contact lens materials is well known in the custom contact lens industry. In fact, we would probably be considered the quality benchmark even by our competitors. Benz materials are characterized by low residuals, precise and isotropic expansion, and large batch sizes. Benz R&D currently makes the highest purity, most consistent hydrophilic and hydrophobic IOL materials, period. An actual comparison of the quality resulting from Benz polymerization technology vs. our competitors polymerization technology is straightforward. Our BenzFlex 26 consistently has a much lower residual monomer content (0.5% vs. 1.1%) and a smaller matrix or pore size (33% smaller) than competitor materials made from the same monomers (see Figures 2 and 3). Another example of quality is shown by examining how completely the UV blocker is covalently bound to the polymer. A substantial difference between BenzFlex 26 and competitor material can be seen in Figures 4 and 5. There are several important reasons for our high quality. First, our quality starts with ultra high purity raw materials. The purity of our raw materials is much higher than that provided as high purity by the chemical companies that currently manufacture 2-HEMA. Our ultra pure, L3 Monomer significantly reduces batch-to-batch variability and lowers the residual monomer content of our hydrophilic IOL materials. Second, our polymerization process is carried out in virgin glass tubes, not the plastic molds of competitor materials. Plastic molds contain many impurities that affect the polymerization process as well as contaminate the resulting polymer, sometimes with toxic components not intended for IOL use. To understand the scope of the contamination from plastic molds, you need only to look up all the types of plasticizers, mold release agents, lubricants and antioxidants commonly found in polypropylene and polyethylene resins. These same chemical contaminants can be found in competitor materials. Virgin glass molds eliminate contamination. Benz has made it a company priority to use virgin glass molds that cost substantially more, but provide the assurance of polymer purity that is essential to Benz Quality. Third, our polymerization process is carried out in a uniquely designed computer controlled chamber capable of polymerization with extreme temperature stability. This polymerization environment, when combined with advanced formulation technology, ultra pure monomer and inert glass molds, allows us to make an extremely consistent, isotropic polymer. The characteristics of the resulting polymer speaks for itself. The data support our claims that we have the most complete polymerization under the most controlled conditions, period. Making Quality claims based on actual data is consistent with our marketing approach which is one based on verifiable product characteristics. Hopefully, this approach will also become an industry standard. Fourth, since our polymerization process was designed and developed by Benz, not adapted from another company s production process (such as old contact lens blank casting processes), our polymerization technology is easily scalable and not labor intensive. This advantage means that we produce IOL blanks in batch sizes that are appropriate for our customer s requirements. Other manufacturers produce batch sizes that are limited. Our current batch sizes range from 40,000 to 80,000 blanks per batch. Large batches increase the reliability of supply as well as provide for more efficient manufacturing because of less batch qualification tests. Figure 5 BenzFlex 26UV No UV-Blocker residual from alcohol extraction of a hydrophilic IOL material (26% water) from BenzFlex 26.

6 Diameter, Thickness, Parallel and Squareness Diameter Distribution for Benz IOL 25UV LOT Thickness Distribution for Benz IOL 25UV LOT mm 24 LSL -3.0s Tag USL +3.0s 36 LSL -3.0s Tag +3.0s USL THE PRECISION GROUND BLANK & IOL 25 UNIVERSAL BLANK mm or mm or mm Frequency 12 6 Frequency mm mm MAX Microns Microns 6 7 (lot size 63,000 blanks) (lot size 63,000 blanks) Figure 6 Figure 7 Figure 8 IOL blanks with consistent and precise dimensions directly benefit your manufacturing process. Benz Research and Development uses unique high-speed processes for converting our high purity polymer into a precision dimensioned blank, Figure 6. We grind blanks automatically to micron tolerances in diameter and thickness, with optimum squareness and parallel, using state of the art machinery and statistical process control to ensure a highly uniform batch. We invested heavily in this high volume equipment and technology so that we could process large batches with precision dimensions. Figures 7 and 8 show typical results for diameter and thickness (in microns) of a batch of Benz IOL 25UV, I25. A large batch of I-25 Natural Yellow is shown in Figure 9. Precision dimensions facilitate auto-loading processes and eliminate the need to electronically locate the surface of the blank before each machining cycle begins on the lathe. This Figure 9 alone eliminates about 5 seconds from every lathe cycle saving significant time and money Edge Height Provided In Data Table 0.23 Clearance A 3 Ø ±0.010 B Section C-C B UM Or Better Lens Concentricity To Mandrel Shank A Figure 9 Figure 10 The new IOL 25 Universal Blank is a precision molded disk, 100% inspected for visual and optical defects and laser mounted on a precision polycarbonate mandrel, see Figure 10.

7 Benz IOL BenzFlex IOL 25 Property Universal Blank Water Content (wt %) Dry 20 C Refractive 589 nm Hydrated 20 C Natural Yellow is superior to other yellow IOL materials because it protects the retina without blocking needed blue light. Blue blocking IOLs reduce low light contrast sensitivity Refractive 546 nm Dry 20 C as well as color perception. These capabilities are critically needed for optimum vision of implant BENZ HYDROPHILIC Hydrated 20 C patients, particularly at night. Benz Natural Yellow achieves complete natural protection Expansion IOL MATERIAL Linear without loss of contrast sensitivity or color perception. The human retina has already specified the Radial Tensile g/mm 2 Diameter (mm) ± ± Young s Modulus g/mm ± ± exact chromophore it needs for energetic light protection through millions of years evolution, and that is exactly the chromophore we deliver to our customers, in Benz Natural Yellow ± ±0.01 Thickness (mm) 3.0± ± Table 1 Benz Research and Development has been manufacturing hydrophilic acrylic IOL materials for many years. During this time, literally tens of millions of IOLs made from Benz materials have been implanted. Our material s reputation in the industry is one of high quality and consistent trouble-free service. The development of Zero Technology will assure our customers that Benz will provide the highest purity polymer available for their implant products for years to come. Benz materials are made in virgin glass molds free of potential contamination from plasticizers, mold release agents, lubricants and anti-oxidants. Benz IOL 25 IOL 25 is our patented hydrophilic material (US Patent No. 6,517,750), especially effective for small bore injectable IOLs. This copolymer of 2-Hydroxyethylmethacrylate and 2-Ethoxyethylmethacrylate has a unique combination of modulus of elasticity and tensile strength that allow the finished IOL to be drastically deformed during injection through openings as smaller than 1.6mm and return to its original shape and optical performance in the most desirable time frame. This material also has a history of very low PCO rates across many designs. The physical properties of Benz IOL 25 are shown in Table 1. Benz IOL25 Universal Blank The Universal Blank is the same material molded as a disk and precision blocked on a disposable precision mandrel. The posterior aspheric optic is complete with a 70 micron square edge (hydrated). A finished lens ready to polish or a polish free lens ready to hydrate require the same manufacturing steps: one rough cut, one fine cut and one milling pass. Polish ready or polish free is determined by the equipment used for the machining step. Deblocking the lens is done mechanically, with only the lens removed. The total cost for a finished IOL25 hydrophilic lens prior to inspection and packaging using this method is <US $4.00 (see Global Contact, issue 2, 2013, article New Methods in Hydrophilic IOL Manufacturing). BenzFlex 26 BenzFlex 26 is a generic material made from 2-Hydroxyethylmethacrylate and Methylmethacrylate. This material s primary components are the same as other products available on the market and has similar mechanical properties. The main differences are that BenzFlex 26UV is made with Benz Zero Technology ultra pure monomer and our superior polymerization technology as well as made in virgin glass molds. There are important quantitative differences resulting from Benz Zero Technology monomer, Benz s superior Polymerization Technology and virgin glass molds. These advantages are: very low residuals, zero ionicity, a smaller matrix (pore size), more precise expansion characteristics than competitor materials and no contamination from impurities found in plastic molds. The physical properties of BenzFlex 26 UV are shown in Table 1. Comparison of 3-HydroxyKynurenine in Saline vs. Benz Natural Yellow Chromophore Absorbance Figure 11 UV-A Blocking Wavelength (nm) BENZ Natural Yellow Chromophore 3-HydroxyKynurenine in Saline Violet Filtering Improved Scotopic Vision Nature s Own Light Filter Benz IOL 25 Natural Yellow and BenzFlex 26 Natural Yellow are the first IOL materials to incorporate the same UV-A blocking and violet light filtering chromophore that is in the human crystalline lens. Our approach to UV blockers and violet filters is to use nature s own solutions to the problem of protecting the retina from harmful energetic light. The absorption spectrum of the chromophore, 2-Hydroxykynureneine (Figure 11) shows that this natural chromophore is an excellent UV-A blocker with a secondary purpose of filtering (not blocking) violet light. This and its beta Glucoside derivative are nature s primary protection for UV-A and violet light. We have made a special monomer (U.S. Patent 7,947,796) containing the identical chromophore present in the human crystalline lens and covalently incorporated it into our premier IOL materials. We call these proprietary natural light filtering materials Natural Yellow. The visible transmission spectrum of Benz IOL 25 Natural Yellow material, 1.0 mm thickness is shown in Figure 12 compared to the transmission spectrum of a young human crystalline lens as defined by van de Kraats and van Norren (OSA, posted February 7, 2007, doc ID 76626). % Transmission Comparison of a Young Lens, M(LY) vs. Benz IOL 25 Natural Yellow M (LY) 80 BENZ Natural Yellow IOL Materials Wavelength (nm) Figure 12

8 ø13.40 ± 0.15 Anterior Side: Spheric (Rf) Lathe Cut to Achieve Desired Power and Surface Type A 0.12 (Front Cut Depth) 0.40± BENZ HF-1.2 R0.04 Square Edge Detail HYDROPHOBIC IOL MATERIAL ø6.00 (OZ) CT ø6.05 Posterior Side: Aspheric (Rb) 5º R0.1 A Section A-A Figure 14 Figure 15 Figure 16 % Transmission Transmission of HF-1.2 Natural Yellow BENZ Natural Yellow Young Lens M (LY) Wavelength (nm) Figure 13 While the Benz hydrophilic materials offer the ultimate in reliability and performance in a highly biocompatible hydrophilic polymer, our HF-1.2 hydrophobic material offers customers a significant additional value added market because of the promotion of hydrophobic materials by the market leaders. We have been developing HF-1.2 material for 9 years and as a result of the latest developments, the opening time has been reduced from 60 seconds to 25 seconds. Because of this improvement, HF-1 is now called HF-1.2. This material has many advantageous characteristics resulting in a high performance IOL: Low chromatic aberration, Abbe number 49 Very low glistenings (well below clinical threshold) Opening time approximately 25 seconds at 25 C Mechanical properties similar to IOL 25UV The Glistening behavior of hydrophobic acrylic rubbers is well known and has been present ever since the first products were introduced in the early 1990 s. One of the most popular hydrophobic IOL materials is the acrylic copolymer: 2-Phenylethylacrylate/2-Phenylethylmethacrylate, the material of the market leading IOL. Recent clinical reports on the extent of the glistenings of market leading products and their clinical significance provide marketing opportunities for new hydrophobic IOL products, such as Benz HF-1.2. We have studied extensively the relationship of glistenings to the manufacturing process parameters in developing the current process for Benz HF-1.2. We have also adopted the Trattler Severity Index as a Quality Assurance procedure for each batch of material. The Severity Index for HF-1.2 batches has been followed for months submerged in saline and does not change from the first 24 hours submerged in saline. The average Severity Index of 85 batches HF-1.2 is compared below to the severity index of the market leading IOL material, see Table 2. Obviously, there is a clear difference with respect to glistenings for these two materials. The reasons are not completely known, but obvious differences in the two materials are the formula components and likely differences in the polymerization processes. The superior quality of Benz HF-1.2 with respect to glistenings is apparent. Benz HF-1.2 Natural Yellow Universal Blank is the same polymer composition as the original HF-1 with the addition of the Benz Natural Yellow UV-A blocking and Violet Filtering monomer (US Patent 7,947,796). Benz Natural Yellow gives HF-1.2 the same light transmission characteristics as a young human crystalline lens. The transmission spectrum of HF-1.2 Natural Yellow is shown in Figure 13, compared to a young lens as described by van de Kraats and van Norren (OSA, posted Feb , doc ID 76626). HF-1.2 Natural Yellow Universal blank has been processed using a special technique to enhance its unfolding characteristics. HF-1.2 Natural Yellow is made using ultra high purity monomer and a state of the art polymerization process to give you a high performance hydrophobic material with the ultimate in reliability. The design of the HF-1.2 Natural Yellow Universal Blank is intended to allow an ease of manufacturing for many Hydrophobic IOL designs. The posterior side of the blank contains a finished spherical optic and a square edge. The diopter powers currently available are 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5 and 30 D. By providing both optical surfaces finished, the optical quality of the part can be easily verified before producing a custom optic on the anterior surface. Custom lens powers less than the universal blank powers are made by simply machining the front. All one piece designs can easily be manufactured using the Benz HF-1.2 Natural Yellow Universal Blank. Figure 14 shows the dimensions of the blank and the amount of material available for producing a custom anterior surface. Manufacturing is as simple as cryogenic machining of the front surface using the Benz cryogenic insert and milling of the haptic. Two manufacturing steps to a finished hydrophobic IOL, Figures 14 and 15. Material Glistening Severity Index Mean Std. Dev Minimum Maximum HF-1.2 1) SA60, SN60 2) 8,589 9, ,361 Table 2 1) Data from Benz Research and Development QA Dept. 2) Aaron Waite, Nathan Faulkner, and Randall J. Olson. Glistenings in the Single-Piece Hydrophobic, Acrylic Intraocular Lenses. J Ophthalmol 2007; 144: Property Benz HF-1.2 Natural Yellow Universal Blank Water <4 Tg C 3.6 Refractive C C Refractive C C Tensile 288 g/mm 2 Modulus 560 g/mm 2 Abbe Number 49 Table 3

9 Benz Natural Yellow Chromophore IOL 25 UV-Vis IOL 25 UVX Extreme Photostability BENZ UV-A BLOCKING MATERIALS Absorbance UV-A Blocking BENZ Natural Yellow Chromophore Violet Filtering % Transmission Benz IOL 25 UV Benz IOL 25 UVX % Transmission Benz IOL 25 UVX Day 0 Benz IOL 25 UVX Day 20 Benz IOL 25 UVX Day 40 using ISO (Annex D) Wavelength (nm) Wavelength (nm) Figure 17 Figure 18 Figure 19 Wavelength (nm) Benz UV-A blocking materials fall into two categories: Natural Yellow and clear UV. Natural Yellow is a unique UV-A blocking and violet light filtering naturally occurring chromophore patented by Benz, US Patent 7,947,796. This exact chromophore is in every human liquid crystalline lens. Nature s intent for this chromophore is readily seen by examining its UV-Visible absorption spectrum shown in Figure 17. As you can see, nature designed its final protection of the retina to be a strong and broad UV-A absorbing chromophore with a maximum absorption centered at 370 nm, extending with lesser absorption to 440 nm, through the violet region of the visible spectrum. Although most UV light is absorbed by the cornea*, the remainder is intended to be absorbed by this chromophore present in the human lens. This is what nature has specified for retina protection and therefore, Natural Yellow IOL materials provide the most appropriate UV protection for a lens replacement material. Clear UV-A blocking materials are IOL materials that block UV-A light only, therefore these materials appear clear, without any yellowish tint. Up until recently, clear UV-A blocking has been accomplished primarily with two classes of chromophores, Benzophenones and Benzotriazoles. Both of these chromophores are in wide use in the IOL industry. Our approach to clear UV-A blocking, until now, has been to provide 10% transmission at 360 nm using a Benzophenone chromophore at a concentration (approx. 0.2%) sufficient for 20 year protection under natural reflected UV-A light conditions after the light has passed through the cornea and the pupil. The current ISO Photostability Test fails to fully account for UV-A absorption by the cornea or account for the pupil size in bright sunlight. This results in the use of unnaturally intense UV-A light in the ISO photostability test, resulting in an unnaturally severe photostability requirement for UV blockers. In addition, there is a current proposal to create a new ISO standard for IOL UV blocking of 10% transmission at 370 nm. This standard would require much, much higher levels of Benzophenone, resulting in water content and refractive index changes to the IOL material, potentially resulting in new clinical testing of many current IOL products. Because of these factors and in order to protect our customers from unnecessary and time consuming clinical tests, we have recently developed a new IOL UV-A blocker with Extreme Photostability and very high UV-A absorption, Benz UVX (patent pending). This new covalently bound UV-A blocker achieves 5% transmission at 370 nm with only 0.15 wt% added to the polymer. This small amount of covalently bound chromophore means no change in water content, refractive index, tensile strength or modulus. The transmission spectrum of Benz IOL 25 UVX and Benz IOL 25 UV is shown in Figure 18. The results of 20 year photostability using ISO (Annex D) test conditions is shown in Figure 19. The small amount of UVX required to meet both the 10% at 370 nm transmission requirement and 20 year photostability requirement means that no properties of IOL 25, BenzFlex or HF-1.2 are altered EXCEPT UV blocking. UVX passes all polymer safety tests, is non-extractable and covalently bound to the polymer. Therefore, no clinical testing is required. Benz UVX is available in all Benz IOL materials. *L. Kolozsvari, A. Nogradi, B. Hopp and Z Bor, UV Absorbance of the Human Cornea in the 240 t 400 nm Range, IOVS, July 2002, Vol. 43, No 7.

10 MACHINING RECOMMENDATIONS Figure 20 Figure 21 Polish Free Manufactured Dry Lens Benz hydrophilic IOL materials can be easily machined to give excellent surface quality by using the proper machining conditions and sharp, proper geometry diamond tools. Conditions and tools are very important and must be controlled for consistent results. Hydrophilic acrylic IOL materials are glassy polymers and machine similar to contact lens plastics. Tables 4, 5 and 6 show a summary of tool and machining parameter recommendations. Using larger tool diameter, greater depth of cut or faster feed rate than recommended can reduce the effective expansion of the material because of induced stress into plastic. To ensure the highest yield, we recommend that each manufacturer verify the radial and linear expansion values given for each lot using their own manufacturing and testing procedures. Benz Hydrophobic materials require cryogenic conditions for optimum machining. Cryogenic temperatures can be easily achieved using commercially available freezing devices that can be attached to the spindle of your existing lathes. Blanks are mounted on a special mandrel using moisture (see Figure 20). The mandrel is cooled to at least -20 C using a vortex freeze station. Once the mandrel is cooled, it is placed in the lathe collet that is fitted with a cryogenic unit. The surface of the blank must be maintained at -20 C or below. The blow-off air must also be adjusted to the same temperature and dry (<-50 F dew point). Use the cutting parameters in Tables 7 and 8. Our newest product, the IOL 25 Universal blank is provided as a molded disk, similar to the HF-1 universal blank and precision blocked on a disposable bar coded mandrel. The product features a hollow mandrel for convenient in-process QC of the optics. The haptic disk has a 5 angulation or 0 angulation (see Figure 21). Tool Radius Top Rake Relief Rough Cut Tool 0.40 mm 0 / Finish Cut Tool 0.30 mm 0 / Table 4 Lathe Tools Benz IOL25 UV and BenzFlex 26 Lathe Parameters Rough Cut Fine Cut Speed (rpm) 10,000 Speed (rpm) 9,500 Tool Feed (mm/min) 89 Tool Feed (mm/min) 26 Depth of Cut (mm) 0.35 Depth of Cut 0.12 Blank Surface Temp (C ) <-20 Blank Surface Temp (C ) <-20 Table 5 Table 6 IOL 25 Universal Blank Lathe & Milling Parameters Rough Fine Milling Milling 1st pass 2nd pass Speed (rpm) 9,000 7,500 50,000 55,000 Tool Feed (mm/min) Depth of Cut (mm) HF-1.2 Natural Yellow Lathe Parameters Rough Cut Fine Cut Speed (rpm) 9,000 Speed (rpm) 9,000 Tool Feed (mm/min) 18 Tool Feed (mm/min) 10 Depth of Cut (mm) 0.13 Depth of Cut 0.07 Blank Surface Temp (C ) <-20 Blank Surface Temp (C ) <-20 Table 7 HF-1.2 Natural Yellow Milling Parameters Rough Cut Fine Cut Speed (rpm) 50,000 Speed (rpm) 50,000 Tool Feed (mm/min) 30 Tool Feed (mm/min) 45 Blank Surface Temp (C ) <-20 Blank Surface Temp (C ) <-20 Table 8 Polish Free Manufacturing Conditions Lathe Tools* Tool Radius Rough Cut Tool.20 mm Finish Cut Tool.20 mm *controlled wave tools required Lathe Parameter* Rough Fine Speed (rpm) Tool Feed (mm/min) Depth of Cut (mm) *Opto Form 80 Lathe Milling Parameters Equipment, Optomill mm x 1.2mm Diamond Endmill (Wiediam Diamonds) 1st & 2nd Cut Feed, 88mm/min, 80,000 rpm 3rd Cut Feed, 91mm/min, 90,000 rpm 1st Cut Stops 0.050mm ( approximately 0.250mm depth) shy of breaking through to wax 2nd Cut Goes 0.050mm ( approximately 0.350mm total) past the lens into the wax 3rd Cut Backs off 0.030mm depth, with a radial cut of mm Cycle time, 150 seconds Environmental 70 ± 3 F (21 ± 2 C) 35 ± 3% RH

11 Isotonic Saline HYDRATION OF BENZ HYDROPHILIC MATERIALS Borate Buffer ph 7.2; 295 mos NaCl 8.01 grams H 3 BO grams Na 2 B 4 O 7 10H 2 O 0.14 grams The weights for the buffered saline formula is based on a 1 liter solution. The borate solution shows excellent performance through the sterilization process (autoclaving) and leaves the lenses free of residue Table 9 Hydration Recommendations for Hydrophilic Intraocular Lenses (IOLs): Hydration of IOLs made from hydrophilic materials is a crucial step in IOL manufacture because it serves two functions. 1. Hydration transforms the plastic into a soft hydrogel. 2. Hydration cleans the lens by removing residuals from the lens. During the hydration process one must follow sterile controls and keep bioburden levels low to ensure no biological growth on the lenses while hydrating. This requires using sterile technique to make the hydration saline solution and in handling and cleaning the lenses. Hydrate the lenses in Borate Buffer ph 7.2 isotonic saline (see Table 9) or similar buffered saline solution. The procedure recommended for hydration is as follows: a) Place the dry, polished IOLs in perforated vials immersed in saline solution (a minimum of 10 ml volume per IOL is recommended) at room temperature for 24 hours with stirring. b) Replace the saline solution with fresh saline solution (a minimum of 10-ml volume per IOL is recommended) and continue to hydrate for an additional 24 hour with stirring. c) After the 48 hour hydration period, the lenses should be removed from the saline and cleaned with a lens cleaning solution (such as Bausch & Lomb lens cleaner) or a basic lab detergent (such as a solution of Tergazyme and water). Use sterile technique. Once hydration and cleaning is complete, the lens power is determined to confirm Diopter and MTF using a measurement method consistent with ISO standards. After measurement of each lens it is recleaned with lens cleaning solution and rinsed thoroughly to remove residual lens cleaner. d) Lenses are now ready for packaging and sterilization. Use sterile technique.

12 BENZ MANUFACTURING TECHNOLOGY

13 Reading # Total Indicated Run (mm) ACHIEVING COLLET TO COLLET PRECISION Ø0.4995± Average [Ø12.687mm±0.0025mm] SD Figure 24 Figure 25 Table 10 Precision and productivity have always been key ingredients for the success of lens manufacturing, both contact lenses and IOLs. Today a modern CNC lathe can produce highly complex geometries with ultra smooth surfaces. These lathes provide excellent precision for one step, but once the part is removed from the collet, precision is lost. Therefore, the lathe s precision has not necessarily resulted in ultra precision lenses because the precision of front side machining is lost during each of two discrete mechanical steps: blocking and second side machining. Significant precision is lost during these steps as the part moves from collet-to-collet. Before the total lens manufacturing process can become very precise, collet-tocollet position repeatability must be improved. We have solved the problem of collet-to-collet precision by using technology specifically developed to address the two components of collet precision: run-out and position. Collet run-out occurs because the collet s center of rotation does not match the lathe spindle s center of rotation. This mismatch of rotational symmetry typically produces a collet run-out of microns. This loss in precision is compounded through blocking and second side machining (3 more collets). The Benz spindle/collet assembly eliminates this inaccuracy. In the Benz spindle the mismatch of the collet to its spindle s spin center is eliminated by precision lapping the collet cone into the spindle shaft until reaching the desired spindle/collet run-out. A portion of the exhaust air from the spindle is also redirected through the collet to prevent swarf from altering the tolerance of the cone-collet surface. The Repeatability of Total Indicated Run-out (TIR) of a Benz Precision Steel mandrel during 10 repeated collet loads on a 4-Axis Lathe, using the Benz spindle/collet Assembly is shown in Table 10. The second component of collet-to-collet precision is repeatability of position. We have solved this by designing a precision dead-length collet and a precision steel mandrel (the blank is mounted with wax onto the mandrel s surface for first side machining), see Figure 24 and 25. Using this precision position dead-length system and precision dimension blanks, it is no longer necessary to measure the position of the surface before beginning first side machining. This saves time on every lathe machining cycle. Figure 24 shows a picture of the Benz mandrel with a precision blank attached and the same mandrel and the centering ring used for wax mounting the blank into the mandrel. The Benz spindle with precision lapped dead-length collet, precision mandrels and blank mounting centering rings are all available as technology products from Benz R&D.

14 Calibration Values (X And Y Axis) for a Typical Set-Up Sequence on the Optical Blocker Note the standard deviation of total position (max-min) repeatability. Part # Center (mm) Y1 (mm) X2 (mm) Y2 (mm) X1 (mm) Max-Min OPTICAL BLOCKING & OPTICAL CRYO BLOCKING Average SD Table 11 Optical Cryo Blocker Optical blocking was invented and patented worldwide by Benz Research and Development in Since building our first machine in 1994, we have greatly expanded the functions and overall capabilities of the Optical Blocker for manufacturing contact lenses and IOLs. The Benz Optical Blocker today represents the only commercially available blocking interface between first side and second side machining that achieves accuracy and precision comparable to the lathes currently used in manufacturing. The Benz Optical Blocker is designed and built to deliver unequaled accuracy and precision through years of trouble free use. Our original blocker is still in use at Benz R&D. The new Laser Blocking feature reduces cycle time and provides in-process QC of aspheric optics. The Benz Optical Blocker provides many manufacturing advantages and can be used as a stand-alone machine operated manually, by robot or fully integrated into an automated system, Benz Integrated Lens Manufacturing. Video Haptic Inspection Figure 26 Optical Blocking eliminates the following common manufacturing problems associated with blocking: Prism error, centration variations, and center thickness variations. Increased yield with improved quality are the obvious benefits of Optical Blocking. Additional benefits to your manufacturing competitiveness that may not be obvious are: Automatically provides micron accurate radius measurement Measures of spherical radius as well as major, minor axis of toric lenses with a permanent record of measurements Laser profiles of aspheric optics Automatically rejects base curves that do not meet tolerance you set Automatically calibrates your lathes for radius and sphere to tolerances that you set and provides a real time process control record of lathe calibrations Specific Features of the Optical Blocker 1. Measures radius of curvature with + 2 microns accuracy 2. Measures both major and minor cylinder radii of toric lenses with + 2 micron accuracy 3. Positions apex of concave and convex lenses with + 2 microns in X, Y and Z 4. Concentric blocking average max min variations in edge thickness of 5 microns, see Table Cylinder alignment of toric lenses on second side mandrel to better than 0.5 accuracy 6. Constant center thickness of lenses + 2 microns 7. Automatically calibrates lathes for radius and sphere 8. Provides dead-length apex blocking constant distance between second side mandrel base and apex of mounted first side lens 9. Includes full automatic, semi-automatic and manual mode of operation 10. Laser profiles of aspheric optics Benz Optical Cryo Blocker Our newest Optical Blocking CNC device is the Optical Cryo Blocker. In order to achieve <10 micron concentric accuracy when blocking the HF-1.2 and HF-2 Universal blanks Benz has developed the fully automated Benz Cryo Blocker. High MTF lenses require concentric accuracy when blocking the first side optic. The Optical Cryo Blocker can feed 2 MLC s in an integrated cell (ILM-C). The blocking sequence is shown below. Dispensing Blocking Water Freeze Blocking the Universal Blank Finished Blocked Part Ready for Machining

15 ILM CRYO ILM-C CRYO MANUFACTURING OF HF-1.2 & HF-2 Cryo Blocker Automated Cryo Manufacturing has been made possible by the development of the Benz Optical Cryo Blocker. As the starting point, the HF-1.2 and HF-2 Universal Blanks have eliminated first side machining of hydrophobic IOLs. The next step in development of Integrated Lens Manufacturing for hydrophobic IOLs is integrating the Optical Cryo Blocker with Cryo MLC s. ILM-C is shown on the opposite page. In ILM-C, 100 part trays of HF-1.2 or HF-2 Universal Blanks are the raw material input. These are fully inspected and bar coded trays of specific diopter parts. Approximately 100 microns of material is removed in two passes and the haptic is milled. Mill / Lathe Combo 1 The blocker cycle is <60 sec from picking the Universal Blank from its tray and blocking on a cryo mandrel and cooled to -28 C. ILM-C, with its robotic part handling, keeps 2-MLC s working at full capacity. When the MLC finishes cutting the lens the cryo mandrel is moved to an automatic station that warms the mandrel, removes the finished lens to a special container, and cleans the mandrel to start another manufacturing cycle. The productivity of ILM-C is >140,000 finished lenses per year when operated 16 hours/day, 250 days/year. One operator is required per shift. Guaranteed yield is 96%. Robot Cleaning Station Mill / Lathe Combo 2

16 10. Packaging & Labeling 1. Order Entry & Customer ID 2. Lens Design ILM-3 Systems Operations: The ILM system has been designed for both function and flexibility. ILM-3 also allows INTEGRATED LENS MANUFACTURING (ILM) the system manager to easily add or delete equipment under its control while remaining in continuous operation. The process manager can select each machine mode, thereby optimizing operation time and allowing for other functions like maintenance, or diamond change, that takes a single machine off line while the remaining equipment remains in automation. Adding cells and rearranging equipment within cells is easy through the secure operator interface. There is no limit to the size of the total ILM-3 system imposed by the Benz Automation Program Figure Hydration & or Inspection 8. Polishing 7. 2nd Side Optics Lathing (Robotic) Automation Software & Database 6. Deblocking & Cleaning (Robotic) 3. Blank Mounting (Robotic) 4. 1st Side Optics Lathing & Milling (Robotic) 5. Optical Blocking (Robotic) Integrated Lens Manufacturing (ILM-3) is a lens manufacturing process developed and refined over the past 13 years. Benz Research and Development has spent millions of dollars developing the component systems and automation technology used in ILM. In ILM each lens manufactured has a discrete identity. This identity is defined by order number and the bar code numbers associated with each portion of the manufacturing process: First side manufacturing and blocking; Second side manufacturing, polishing and hydration Inspection, packaging and labeling All data associated with each lens, including the order, and all manufacturing data from each step is saved in the Oracle 10 database of ILM-3. The Benz Automation Program is a large C program that coordinates all automation steps and storage of all data associated with each order including machining parameters created by the front end Design Program for use in each manufacturing step. The Benz Automation Program also coordinates the activities and movements of the tray feed system, blank mounting, lathes, optical blocker, drill, deblocker and robots. Figure 27 illustrates the flow of information and instructions including all robot moves and bar code reads coordinated by the automation program. ILM is designed for robotic handling of parts. Manual part handling can be substituted for robots, but with a substantial loss in productivity. ILM operated with robots will require approximately 1/8 of the manpower of a traditional manufacturing process. Also, all lathe calibration for radius and sphere are automatically performed using ILM. This further reduces total manpower because all lathe calibration is done manually in a traditional manufacturing process. ILM utilizes the following manufacturing technology in a fully integrated system: The Benz precision spindle/collet assembly with Benz mandrels The Benz Optical Blocker with high speed Laser Blocking The Benz IOL Drill The Benz Tray Feed System The Benz Automatic Blank Mounting System The Benz Automatic Deblocking System The Benz Solvent Cleaning System The Benz ILM Automation Program utilizing an Oracle 10 database Custom ILM part handling robot effectors Re-calculation of the second side radius for every part based on the actual measured first side radius Real-time re-calibration of all lathes for radius and sphere Design front end program for spherical and toric lens designs that is accessible for further customization by each manufacturer. Windows-based operator interface for all manufacturing operations including Order-Entry, Maintenance, Quality Control, Inspection, and Auto Calibration Automatic laser profiling of aspheric surfaces Automatic video inspection of haptic milling ILM-3 Manufacturing Sequence The first step to starting ILM-3 is loading clean mandrels in trays into the Tray Feed System, making sure that the vibratory hopper is full of blanks and the wax applicators on the Automatic Blank Mounting Machine and Optical Blocker are full. The next step is to calibrate the lathes Y-Axis to the Optical Blocker Z-Axis and verify the concentricity of the Blocker. This will take 1 hour or less. Now IOL lenses can be ordered in any combination from singles to hundreds at the Order Entry Terminal. Finished lenses on their second side mandrels and used first side mandrels are returned to their trays in the Tray Feed System. Each tray of mandrels and lenses can be conveniently handled and cleaned using the trays with the Benz Solvent Cleaning System.

17 Production Results for Lathe 002 Production Error Mean = 1.8 µm SD µm 60.0 µm 40.0 µm Production Calibration ILM-3 RO Error (microns) 20.0 µm 0.0 µm µm Measurement µm µm 28 13:00 13:30 14:00 14:30 15:00 15:30 29 Figure 28 Auto-Lathe Calibration One of the unique features of the ILM-3 is auto-lathe ILM-3 calibration. This feature allows for automatic adjustments to be made to all the lathes in this system for radius and sphere. During initial start-up, two calibration parts are DAC MLC machined on each lathe, one to calibrate and a second to verify both the radius and the sphere. During the production Optical Blocker day, calibration parts are automatically run on the lathes in the system at an interval chosen by the operator. Production parts can also be used for calibration. Lathes are maintained Blank Mounting, Deblocking and Cleaning to tighter operational tolerances using the precision of the Optical Blocker inspection and the auto-calibration feature. All first side lathes are 100% monitored because all first sides are optically inspected before being blocked. An example of a DAC ALM calibration record and its optical blocker radius measurements are shown in Figure 28. Productivity of ILM The productivity of ILM has been extensively studied at BRD. Transfer Track We have used a 3-cell system in full production for almost eight years. With this level of experience, Benz Research and Development will guarantee the productivity of your ILM-3 system. DAC MLC Tray Feed System DAC MLC DAC MLC

18 ILM Performance Comparison of 1st Side Optics Radius and Semi-Finished IOL to Target Parameters 20 D Before Polishing After Polishing Confidence (R2) = Target mm Target mm Target mm Target mm Power MTF Power MTF 32 1st Side Dry Lathe - Cut IOL Barcode # Measured Radius Center Thickness Haptic Thickness OZ Diameter ILM PERFORMANCE VALIDATION AVERAGE AVG SD SD Figure 29 Table 13 Table 14 Measured Final Power (Dpt) ILM Performance To determine the true accuracy of ILM we have made many tests utilizing groups of 120 identical lenses and measured each lens both dry and wet on a Rotlex IOLA. We also calculated what the wet power should be from the measured dry power and compared this to the actual measured wet power. The results of over 200 of these tests are shown in Figure 29. As the data clearly show, the accuracy and precision of ILM is extremely high, especially when you consider that half of the measured standard deviation of sphere measurements is due to the lens analyzer error. The excellent accuracy and precision of ILM drastically reduces the amount of inspections needed to insure the power and MTF of production lenses. Validation of ILM As with any automated system, process validation is the key to ensuring product consistency and quality. This is particularly important with hydrophilic IOLs because the material requires both accuracy in dry manufacturing and consistent expansion during hydration to hit the desired power and dimensional targets. Benz IOL material is perfectly suited for ILM because of its precision expansion properties. To validate the ILM system we selected a symmetrically biconvex spherical lens, C-loop design, manufactured from one specific lot of hydrophilic IOL material (Benz-IOL 25), see Table 12. Manufacturing Parameters for Lenses from ILM Calculations Data Input ILM Calculation Final Lens Diopter Radius (mm) Center Thickness (mm) OZ Diameter (mm) Table 12 Sample lenses were randomly selected from production orders consisting of 120 lenses of each power, manufactured using the ILM system. Following lathing the 1st side optics and milling the haptics, each part is precision blocked, in the optical blocker, after the optics have been examined and centered and the radius measured. This radius data is used to re-calculate the target radius on the 2nd side optic to ensure optimum target hitting. Second side optic is then lathe-cut and the dry IOL de-blocked and cleaned. A sample size consisting of 60 lenses was selected at random from each Diopter batch. Out of this sample, a set of thirty (30) lenses were hydrated directly after lathing (before dry polishing) and a second set of thirty (30) lenses were polished using the Benz proprietary dry-polish process followed by hydration. While in the dry-state, we measured each lens OZ diameter, center thickness and haptic thickness. Table 13 shows the measured radius of 12 randomly selected 20 D lenses from a 120-part order along with the data for CT, haptic thickness and optic diameter. Using an IOLA model # V from Rotlex, the Diopter power and MTF of the hydrated lenses were determined for both sets, before and after polishing. MTF offers a display of fringe patterns that give visual information on imperfections in the IOL and can be indicative of defects in a manufacturing process. Table 14 shows the data for 14 lenses randomly selected from the set of Diopter lenses. Finally, Table 15 shows a summary of the evaluation data demonstrating the precision and accuracy of the Benz ILM system. These validation results indicate that when using the ILM system to manufacture IOLs, QA time can be significantly reduced because ILM can be validated for statistical sampling and analysis for power. ILM results in higher yields, optimum target hitting, reduced parameter inspection and significantly higher productivity. Validation of the ILM system, per ISO standards, is part of the package when purchasing a complete ILM system from Benz Research and Development. ILM performance is guaranteed. Summary of the Data for All Lenses IOL Power (Dpt) Target Measured Dimension (mm) Center Thickness SD OZ Diameter SD Hydrated Power (dpt) Before Dry Polishing SD After Dry Polishing SD MTF Before Dry Polishing 0.43 min 0.43 min 0.43 min SD After Dry Polishing 0.43 min 0.43 min 0.43 min SD Table 15

19 ILM-3 Direct Cost of Intraocular Lenses Manufactured in the ILM-3 System Hours Estimated Daily Item Quantities Cost Description Expense Number of BLANKS 1125 $ % yield $1, Per Day 22.5 hrs Average Production 24hr $15.00 x 1.2 $ Operator Cost x 24 Average Consumable 22.5 hrs $80.00 Including $80.00 Costs Polishing Environmental Requirements Temperature 21ºC + 2 RH 37% + 5 at 21ºC Air 90 psi at -60C Dew Point 2-Lathe System, 12 CFM 4-Lathe System, 20 CFM BENZ RESEARCH & DEVELOPMENT Registered to ISO : 2003 File No. A7130 Subtotal Cost Per Day $2, Electrical 2-Lathe System, 6 KVA Add Daily Overhead Cost at 25% $ Total Direct Cost Per Day $2, UPS 4-Lathe System, 10 KAV Daily 98.5%, 1108 lenses 32 Direct Cost Per Lens $ V single phase 33 Table 16 The ILM-3 Quality System The Benz Integrated Lens Manufacturing Process was developed with quality products in mind and is part of the overall Quality Management System of Benz Research and Development. ILM-3 is compliant with the stringent quality system requirements of ISO 13485, which embraces the principals of good manufacturing practices and quality system regulations. These quality standards and regulations satisfy the specific quality management requirements for the development and manufacture of medical devices. Per Day Profitability for An ILM-3 Four Lathe System Based on the above example, productivity is 1108 machined lenses per day at a direct cost of US $2.48 per IOL 25UV lens. The estimated profitability [(Productivity x ASP) Direct Cost = Profit] using an average sale price (ASP) per unit of US $20.00 would be about $19,060 per day. ILM-3 Expandability The ILM-3 software provides for unlimited expansion of production cells. No additional software is required to operate increasingly larger systems. To increase capacity starting with a 2-lathe ILM-3 system, you simply add 2 more lathes. To increase capacity starting with a full 4 lathe ILM-3 system you would need a new ILM-3 System, but with only 2-lathes to start and no new software, only a faster server. ILM-3 offers expandability without the headaches of expensive training, turnover, hourly rate growth and an ever expanding work force. ILM-3 keeps your cost of goods under control for years to come. As a result, ILM-3 is a fully documented, controlled and validated process that delivers a product of consistently high quality. ILM-3 is a turn-key process. Currently ILM-3 is fully validated for automated manufacture of biconvex IOLs from +8 to +35 D. Extensions to this range or optics other than spherical biconvex such as torics, require only additional validation tests to be performed not a change in ILM-3. ILM-3 is also fully validated for statistical verification of power and MTF. Because of the validated accuracy and repeatability of ILM, 100% inspection of IOLs for power is not required, only statistical verification in accordance with your specific ANSI AQL Standard. Profitability of ILM-3 Using Table 16 you can determine the appropriate gross profit potential of an ILM production cell shown in Figure 30. The following assumptions have been made: A 24 hours/day operation (1 hour set-up and calibration, 22.5 hours of production) Use 4 DAC MLCs Average yields of 98.5% through machining. Yields are guaranteed and based on our experience manufacturing semi-finished lenses. Space Requirements ILM [7.200m] 224 [5.700m] Figure 30

20 BENZ UNIVERSAL BLANK MANUFACTURING (UBM)

21 UNIVERSAL BLANK MANUFACTURING (UBM) Figure 31 Figure 32 Figure 33 Manufacturing hydrophilic IOLs from Benz IOL 25 Universal Blanks The IOL 25 Universal Blank is a precision molded IOL blank containing a haptic disk and two precision molded optical surfaces, optically blocked onto a low run-out disposable mandrel containing a 2D barcode. The advanced features of Integrated Lens Manufacturing (ILM) are built into each Universal Blank, providing the manufacturer a means to achieve the same production efficiency and manufacturing precision as ILM. Drawings of the IOL 25 Universal Blank and Mandrel are shown in Figures 9 and 10. Front and side views of actual Universal Blanks shown in Figures 31 and 32. As you can see from the above images, the Universal Blank looks very much like a part in ILM production that is about to be second side finished cut and milled, that is because it has been produced with all of the technology of ILM and more, including extremely accurate optical blocking. Also, the data contained in ILM for an individual part at this stage of production is provided with each shipment of Universal Blanks, including the addition of a full optic inspection that is not available from ILM or any other IOL manufacturing process for that matter. The IOL 25 Universal Blank represents a unique assembly of highly advantageous manufacturing technologies in a ready to use form that is produced by Benz Research and Development s Quality Manufacturing Team in the high volumes demanded by our customers to meet the ever growing IOL market. Custom optics are also available with appropriate minimum volume contracts. The Benz Universal Blank requires a minimum of capital investment to achieve a new level of precision manufacturing and only a modest additional investment to achieve fully automated precision machining. The minimum requirement for high precision machining is a very low TIR dead stop collet/spindle of mm or better. An example of such a spindle is shown in Figure 33. Figure 34 High precision, Fully Automated Manufacturing can be achieved using a DAC MLC with Benz Autoloader and data acquisition software. Benz Research and Development provides a fully validated Universal Blank Manufacturing (UBM) System utilizing the DAC MLC. We will provide all documentation for EN13485 validation and certification plus a production deblocking and cleaning system (100 parts per cycle) at no charge. Also, with the UBM system, polishing time is approximately 14 hours using the Benz Dry Polishing Process. Polish free lenses can be made from the Universal Blank using the Optoform 80 Lathe (see Global Contact, issue 2, 2013, article New Methods in Hydrophilic IOL Manufacturing).The Universal Blanks are shipped in foil packaging in ready to use barcoded trays of 100 parts, see Figure 34. Figure 35 Figure 35 shows 5 trays of Universal Blanks being loaded into the autoloader. Please, read our article in Global Contact on Automated Manufacturing using the IOL 25 Universal Blank.

22 Benz Research and Development has implemented a major program towards renewable energy and conservation. Beginning in the summer of 2007, Benz Research and Development installed a 25,000 watt solar panel array and began a comprehensive program to examine energy use. This has resulted in several important energy conservation projects that have reduced our electrical power demand by 50,000 watts. Our current energy conservation projects include 250 KW of gas turbine power combined with a high efficiency heat recovery system to provide 1,080,000 BTUs of air conditioning via LiBr absorption chillers and 400,000 BTUs of process hot water. The overall efficiency of our Combined-Heat-and-Power system (CCHP) is approximately 70%, which has helped us to further trim our electrical power demand by 100,000 watts. benzrd.com