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MODEL SN60AT - 9 Pages

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PRODUCT INFORMATION Alcon Laboratories, Inc. CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. Model Characteristics Chart Model Haptic Angle DESCRIPTION AcrySof® Natural UV and blue light filtering acrylic foldable single-piece posterior chamber lenses are optical implants for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients. AcrySof® Natural with Alcon’s proprietary blue light filtering chromophore filters light in a manner that approximates the human crystalline lens in the 400 - 475 nm blue...

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SPECTRAL TRANSMITTANCE CURVES Figure 2 NOTES: • The cutoff wavelength and the spectral transmittance curves presented here represent the range of transmittance values of IOLs made from acrylate/methacrylate copolymer with bonded UV-absorber and Alcon’s proprietary blue light filtering chromophore. • Measurements were direct transmittance using a 6 mm aperture and a disc of thickness equivalent to the optic center. • Human lens data from Boettner and Wolter (1962). Table 1 Transmittance Comparison for 20.0 D IOLs, % Model Transmittance Reduction with SN60AT (% of SA60AT) MODE OF ACTION...

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14. Chronic uveitis 15. Diabetic retinopathy 16. Clinically significant macular/RPE changes 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. WARNINGS 1. As with any surgical procedure, there is risk involved....

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After opening the cardboard storage container, verify lens case information (e.g., model, power, and serial number) is consistent with information on outer package labeling. To remove the lens, open the pouch and transfer the case to a sterile environment. Carefully open the case to expose the lens. When removing the lens from the case, DO NOT grasp the optical area with forceps. Prior to the actual folding process, the lens should be handled by the haptic portion only. Rinse the lens thoroughly using sterile intraocular irrigating solution such as BSS® or BSS PLUS®. DO NOT rinse the lens...

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AcrySof® Natural SINGLE-PIECE LENS Model SB30AL VISUAL ACUITY A summary of visual acuity achieved at a minimum of one year postoperatively among subjects who did not have preoperative ocular pathology, abnormal corneas, or macular degeneration at any time (Best Case) is presented in Table 2a, and visual acuity achieved by overall subject population is shown in Table 3a. Control data are found for the same data sets in Tables 2b and 3b, respectively. There was no statistically significant difference in visual acuity between Model SB30AL and the control lens, Model SA30AL, in either the best...

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Table 3b Best Corrected Visual Acuity in the Overall Patient Population at a Minimum of One Year Postoperatively, AcrySof® IOL SA30AL control #Per AcrySof® Natural SINGLE-PIECE LENS Model SB30AL CUMULATIVE ADVERSE EVENTS The cumulative rates of these adverse events up to and including a minimum of a one year postoperative period for the AcrySof® Natural Single-Piece Lens Model SB30AL and the Model SA30AL patients are shown in Table 4. There were no statistically significant differences between the Model SB30AL and the Model SA30AL for the proportion of subjects experiencing any of the...

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Table 5 Persistent Adverse Events at a Minimum of One Year Postoperatively AcrySof® Natural IOL SB30AL and SA30AL control SB30AL (N= 138) N % Type of Adverse Event Persistent Corneal Edema Iritis Macular Edema Vitritis Raised IOP Requiring Treatment *p-values from Fisher’s Exact Test comparing Model SB30AL to Model SA30AL. AcrySof® Natural SINGLE-PIECE LENS Model SB30AL COLOR PERCEPTION Color perception testing using the Farnsworth D-15 Panel Test was conducted at the 120 to 180 day postoperative period. Of the 109 subjects with normal color vision implanted with a Model SB30AL in the first...

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REFERENCES Boettner, E.A. and Wolter, J.R. Transmission of the ocular media. Invest. Ophthalmol. 1:776-783, 1962. Girard, L.J., et al. Complications of the Simcoe Flexible Loop Phacoprosthesis in the anterior chamber. Ophthalmic Surg. 14(4):332-335, 1983. Holtz, S.J. Postoperative capsular bag distension. J. Cataract Refract. Surg. 16(5):310-317, 1992. Willis, D.A., et al. Pupillary block associated with posterior chamber lenses. Ophthalmic Surg. 16(2):108-109, 1985. SYMBOLS USED ON LABELING SYMBOL Intraocular lens Posterior chamber Posterior chamber lens Body diameter (Optic diameter)...

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