*Simulated vision. **Individual results may vary and are not guaranteed. Visual Performance When It s Needed Most
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1 Simulated vision. Individual results may vary and are not guaranteed. Visual Performance When It s Needed Most
2 The aspheric design of the AcrySof IQ IOL results in improved clarity and image quality. The Reassurance of Excellent Image Quality Proven to deliver excellent visual performance in even the most challenging situations, the AcrySof IQ IOL provides the confidence of: Reduced spherical and total order aberrations 1 Improved functional vision in all conditions 1 Increased mesopic contrast sensitivity 1 Over 60 million AcrySof IOL implants worldwide 2 CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: AcrySof IQ posterior chamber intraocular lens is intended for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag. Please refer to the back cover for important safety information for AcrySof IQ IOLs.
3 Aspheric Design After analyzing more than 700 corneas, 3 the AcrySof IQ IOL was engineered with a negative spherical aberration to compensate for the positive aberration of an average cornea. This aspheric design results in dramatically improved clarity and image quality with reduced aberrations. Spherical IOL Aspheric IOL Spherical Aberration Positive spherical aberration occurs when light rays are over-refracted at the periphery of a spherical IOL. An aspheric IOL correctly aligns the light rays to adjust for positive corneal spherical aberrations. = paraxial focal point = marginal focal point Image Quality 1 The AcrySof IQ IOL delivers a mean ocular spherical aberration of approximately 0.1µ. When compared to a spherical IOL control, the AcrySof IQ IOL showed a statistically significant reduction in spherical and total higher order aberrations. 1 Spherical and Total Higher Order Aberrations Days After 2nd Eye Implant Aberrations (μm) Spherical Aberration AcrySof IOL (n=73) Total Higher Order Aberrations Control (n=73) Differences favor AcrySof IOL overall and at each visit (p<0.0001). AcrySof IQ IOL showed statistically significant reduction in both spherical and total higher order aberrations.
4 Functional Vision 1 The AcrySof IQ IOL has demonstrated statistically significant superiority under a wide range of extremely difficult visual conditions. By allowing greater reaction times in these situations, surgeons can count on improved patient safety and satisfaction. Nighttime Driving 1 Driving at night is a common cause of anxiety among cataract patients. Adding obstacles such as fog, glare and high speeds represents an even greater risk. Under similar conditions when measured against a control lens, the AcrySof IQ IOL: Performed functionally better in 34 of 36 conditions Improved functional vision under real-world challenges Allowed patients more time to take appropriate action Please refer to the back cover for important safety information for AcrySof IQ IOLs.
5 A subset of patients underwent testing in a validated night driving simulator. Patients were tested monocularly under conditions which simulate city and rural settings under normal, glare and fog conditions. Mean Intra-Individual Differences (Versus the Control Lens) in Identification Sight Distances (n=44) City (35 mph) Rural (55 mph) Normal Glare Fog Normal Glare Fog Differences (Feet) Differences (Feet) Distance difference equivalent to 0.5 seconds Distance difference equivalent to 1.0 second p<0.05 Additional Stopping Distance With AcrySof IQ IOL (in a rural setting in fog conditions at 55 mph) 130 FEET (more than 1 second additional reaction time) AcrySof IQ IOL patients had an average increase of 130+ feet (versus the control lens) in which to stop after identifying a warning sign. Results of a controlled, randomized, double-masked, multicenter, contralateral implant clinical study of the AcrySof IQ IOL versus an AcrySof Single-Piece IOL (SA60AT). See Directions for Use.
6 Contrast Sensitivity The AcrySof IQ IOL is engineered to excel in low-light conditions, improving contrast sensitivity and functional vision for patients when they need it most. 1 Contrast Sensitivity in Mesopic Conditions 1 Light Filtration Filtering both UV and high-energy blue light, the proprietary AcrySof IOL chromophore more closely approximates the light transmission of a human lens. Compared to UV-only IOLs, the AcrySof IOL chromophore achieves excellent: Visual performance in all lighting conditions 3-5 Contrast Sensitivity (log units) CPD With Glare 6 CPD Without Glare Contrast Level/Condition AcrySof IQ IOL (n=75) AcrySof Single-Piece IOL (n=75) p= p= Color perception across the spectrum 5,6 Spectral Transmittance Curves 1 Transmittance (%) Contrast sensitivity was measured using Vector Vision CSV Wavelength (nm) AcrySof IQ SN60WF Lens UV-Filtering SA60AT Lens 4-53 yr. old range, crystalline lens Note: The safety and effectiveness of intraocular lens implants have not been substantiated in patients with preexisting ocular conditions (chronic drug miosis, glaucoma, amblyopia, diabetic retinopathy, previous corneal transplant, previous retinal detachment, and/or iritis, etc.). Physicians considering lens implantation in such patients should explore the use of alternative methods of aphakic correction and consider lens implantation only if alternatives are deemed unsatisfactory in meeting the needs of the patient. Please refer to the back cover for important safety information for AcrySof IQ IOLs.
7 The Power of a Proven Platform Built on the proven AcrySof platform, the AcrySof IQ IOL shares the same benefits of the entire AcrySof IQ family: CONFIDENCE Excellent Biomechanics Single-piece design for rotational stability Specifications Optics Aspheric Design Corneal Aberration Correction Thin Optic Profile Patented STABLEFORCE haptics for capsular bag stability Optimal Biomaterials High refractive index for thinner IOL profile UV and blue-light filtration Materials Hydrophobic Acrylic High Refractive Index UV and Blue-Light Filtration Design Single-Piece Suggested A-Constant Advanced Optics Proven aspheric design for image quality Thin edge profile IOL Delivery System MONARCH III Delivery System AcrySert Delivery System Provided as a guideline only. Ease of Implantation 1,7 Consistent design Consistent delivery Predictably unfolds Easier centration 13.0 mm 6.0 mm Anterior Aspheric Lens Surface Posterior Optic Surface Trusted Leadership Over 60 million AcrySof IOL implants 2 Backed by the Alcon network of support Front View AcrySof IQ IOL Side View Bench data on file: Monarch Delivery Systems. Please refer to the back cover for important safety information for AcrySof IQ IOLs.
8 IMPORTANT SAFETY INFORMATION: AcrySof IQ IOL CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The AcrySof IQ posterior chamber intraocular lens is intended for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag. WARNING/PRECAUTION: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Caution should be used prior to lens encapsulation to avoid lens decentrations or dislocations. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof Natural IOL and normal color vision. The effect on vision of the AcrySof Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45 C; use only sterile irrigating solutions such as BSS or BSS PLUS Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. AcrySof IQ Toric IOL CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The AcrySof IQ Toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision. WARNING/PRECAUTION: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Toric IOLs should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation. All viscoelastics should be removed from both the anterior and posterior sides of the lens; residual viscoelastics may allow the lens to rotate. Optical theory suggest, that, high astigmatic patients (i.e. > 2.5 D) may experience spatial distortions. Possible toric IOL related factors may include residual cylindrical error or axis misalignments. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof IQ Toric Cylinder Power IOLs. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof Natural IOL and normal color vision. The effect on vision of the AcrySof Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45 C; use only sterile irrigating solutions such as BSS or BSS PLUS Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. AcrySof IQ ReSTOR IOL CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag. WARNING/PRECAUTION: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery. Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. Clinical studies with the AcrySof ReSTOR lens indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof IQ ReSTOR IOLs. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof Natural IOL and normal color vision. The effect on vision of the AcrySof Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45 C; use only sterile irrigating solutions such as BSS or BSS PLUS Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. 1. Results of a controlled, randomized, double-masked, multicenter, contralateral implant clinical study of the AcrySof IQ IOL versus a spherical control lens (AcrySof Single-Piece IOL Model SA60AT). See AcrySof IQ IOL Directions for Use. 2. Data on file. Alcon R&D Technical Report. 3. Greenstein V, et al. Scotopic sensitivity and color vision with a blue-light-absorbing intraocular lens. J Cataract Refract Surg. 2007;33: Espindle D, et al. Quality-of-life improvements in cataract patients with bilateral blue-light-filtering intraocular lenses: clinical trial. J Cataract Refract Surg. 2005;31: Muftuoglu O, et al. Effect of a yellow intraocular lens on scotopic vision, glare disability, and blue color perception. J Cataract Refract Surg. 2007;33: Augustin AJ, et al. The physiology of scotopic vision, contrast vision, color vision, and circadian rhythmicity: can these parameters be influenced by blue-light-filtering lenses? Retina Independent third party research; Data on file, December Novartis 1/12 NIQ11394SA AlconSurgical.com
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