PRODUCT INFORMATION Alcon Laboratories, Inc. R

PRODUCT INFORMATION Alcon Laboratories, Inc. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Model Characteristics Chart Model Optic Type Haptic Angle Anterior Asymmetric Biconvex DESCRIPTION The AcrySof® IQ UV and blue light filtering acrylic foldable single-piece posterior chamber intraocular lens (IOL) is an optical implant for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. The AcrySof® IQ lens with Alcon’s proprietary blue light filtering chromophore filters light in...

Figure 2 Spectral Transmittance Curves crystalline lens 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 by direct transmittance using a 6mm aperture and a disc of thickness equivalent to the optic center. • Human lens data is from Boettner and Wolter (1962). Table 1 Transmittance Comparison for 20.0 D IOLs, % Model Transmittance Reduction with SN60WF (% of SA60AT)...

MODE OF ACTION The AcrySof® IQ posterior chamber intraocular lens is intended to be positioned in the posterior chamber of the eye, replacing the natural crystalline lens. This position allows the lens to function as a refractive medium in the correction of aphakia. The aspheric biconvex optic reduces spherical aberration as compared to a standard spherical optic in an average eye. The effectiveness of this lens in reducing the incidence of retinal disorders has not been established. INDICATIONS The AcrySof® IQ posterior chamber intraocular lens is indicated for the replacement of the human lens...

Postoperative distension of the capsular bag with variable amounts of anterior chamber shallowing and induced myopia have been associated with capsulorhexis techniques and implantation of PMMA, silicone and acrylic posterior chamber lenses (Holtz, 1992). 10. Caution should be used prior to lens encapsulation to avoid lens decentrations or dislocations. Some clinical cases suggest encapsulation occurs within four weeks. 11. The clinical study of the AcrySof® Natural Single-Piece Lens (referenced in Tables 2 through 5) was conducted with the lens intended for implantation in the capsular bag only....

CALCULATION OF LENS POWER Preoperative calculation of required lens power for these posterior chamber intraocular lenses should be determined by the surgeon’s experience, preference, and intended lens placement. Lens power calculation methods are described in the following references: Hoffer, K.J. The Hoffer Q formula: A comparison of theoretic and regression formulas. J. Cataract Refract. Surg. 19:700-712, 1993. Holladay, J.T., et al. A three-part system for refining intraocular lens power calculations. J. Cataract Refract. Surg. 14:17-24, 1988. Holladay, J.T., et al. Standardizing constants...

Table 2b Best Corrected Visual Acuity in the Best Case Patient Population at a Minimum of One Year Postoperatively, AcrySof® Lens SA30AL control Acuity 20/20 or Better N % Table 3a Best Corrected Visual Acuity in the Overall Patient Population at a Minimum of One Year Postoperatively, AcrySof® Lens Natural SB30AL Acuity 20/20 or Better Table 3b Best Corrected Visual Acuity in the Overall Patient Population at a Minimum of One Year Postoperatively, AcrySof® Lens SA30AL control Acuity #Per N

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 cumulative adverse events. Table 4 Cumulative Adverse Events at a Minimum of One Year Postoperatively AcrySof® Natural Lens SB30AL and SA30AL control SB30AL...

AcrySof® Natural SINGLE-PIECE LENS Model SB30AL Nd:YAG RATES With a mean follow-up of 21.6 months, three (3) of the 135 subjects (2.2%) implanted with SB30AL experienced a Nd:YAG posterior capsulotomy. With a mean follow-up of 21.9 months, two (2) of the 127 subjects (1.6%) implanted with SA30AL experienced a Nd: YAG posterior capsulotomy. AcrySof® IQ LENS CLINICAL STUDY Consistent with the design of similar previously conducted IOL studies, adult subjects in good general ocular health (e.g. no prior ocular surgery, degenerative visual disorder which would significantly impact visual acuity,...

Figure 5 Mean Spherical Aberration Overall and by Age Group 90-120 Days after 2nd Eye Implant Control Mean Spherical Aberration (micrometers) * AcrySof® IQ LENS – DISTANCE VISUAL ACUITY The AcrySof® IQ lens and the control lens provided clinically similar postoperative visual acuity. Monocular visual acuity results are presented in Figures 6 and 7. Figure 6 LogMAR BCVA Days Postoperative * Quantitative Lens Model Main Effect (p=0.0214)

LogMAR UCVA ■ AcrySof® IQIOL (N=77) □ Control (N=75) 1-2 Days 7-14 Days 30-60 Days Days Postoperative Differences are not statistically significant AcrySof® IQ LENS -CONTRAST SENSITIVITY The primary objective of the clinical investigation was to demonstrate superiority of the AcrySof® IQ lens over the control lens via mean contrast sensitivity measured postoperatively under mesopic conditions with or without glare at either of two spatial frequencies (3 or 6 cycles per degree) using the Vector Vision CSV-1000 (with chart luminance of 3 cd/ m2). In a subset of patients, the Functional Acuity Contrast...

Figure 9 Mesopic Contrast Sensitivity (FACT) Substudy Minimum of 90 days after 2nd Eye Implant Contrast Sensitivity (Log Units) Contrast Level/Condition * Hommel’s adj p-value AcrySof® IQ LENS – NIGHT DRIVING SIMULATION 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. The nighttime city driving scene employs a variety of street lights, car lights, store lights and signs to recreate the high level of ambient lighting typical under these...