40-500-050-002 PRODUCT INFORMATION Alcon Laboratories, Inc.

PRODUCT INFORMATION Alcon Laboratories, Inc. STERILE UV-Absorbing Acrylic Foldable Multipiece Posterior Chamber Lenses 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 DESCRIPTION AcrySof® Natural UV and blue light filtering acrylic foldable multipiece posterior chamber lenses are optical implants for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. AcrySof® Natural IOL with Alcon’s proprietary blue light filtering...

Figure 2 SPECTRAL TRANSMITTANCE CURVES (PERCENTAGE OF ULTRAVIOLET TRANSMITTANCE) 4 yr - 53 yr old range, crystalline lens WAVELENGTH (nm) 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 Transmission Comparison...

Zonular separation (preventing fixation of IOL) Color vision deficiencies Glaucoma Chronic uveitis Diabetic retinopathy 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...

SUGGESTED A-CONSTANT The constant listed on the outer label is presented as a guideline and is a starting point for implant power calculations. It is recommended that you develop your own constant appropriate for you based on clinical experience with the particular lens models, surgical techniques, measuring equipment, and postoperative results. In the United States, if additional information on lens power calculation is needed, please contact Alcon Laboratories, Inc. at 1-800-TO-ALCON (1-800-862-5266). Outside the United States, contact local Alcon offices or distributors. DIRECTIONS FOR USE...

Table 2a Best Corrected Visual Acuity in the Best Case Patient Population at a Minimum of One Year Postoperatively, AcrySof® Natural IOL SB30AL #Per Table 2b Best Corrected Visual Acuity in the Best Case Patient Population at a Minimum of One Year Postoperatively, AcrySof® IOL SA30AL control #Per Table 3a Best Corrected Visual Acuity in the Overall Patient Population at a Minimum of One Year Postoperatively, AcrySof® Natural IOL SB30AL #Per Table 3b Best Corrected Visual Acuity in the Overall Patient Population at a Minimum of One Year Postoperatively, AcrySof® IOL SA30AL control #Per AcrySof®...

Table 4 Cumulative Adverse Events at a Minimum of One Year Postoperatively AcrySof® Natural IOL SB30AL and SA30AL control SB30AL (N= 153) N % Hypopyon Intraocular Infection / Endophthalmitis Macular Edema Pupillary Block Retinal Detachment or Retinal Detachment Repair Lens Dislocation Secondary Surgical Reintervention Removal of Residual Cortex Explant (dislocation due to capsular rupture) Cryotherapy to Repair Retinal Tear Paracentesis to Lower IOP Focal Laser Treatment Photodynamic Therapy Explant Due to Biometry Error Hyphema *p-values from Fisher’s Exact Test comparing Model SB30AL to Model...

PATIENT POPULATION The patient population in the clinical studies consisted of 61.1% females and 38.9% males. Stratifying by race, 94.5% were Caucasian, 3.2% were Black, and 2.1% were Other. The mean age for the total population was 66 years. VISUAL ACUITY The following is a summary of visual acuity achieved at one year and three years (Tables 6 and 6A) postoperatively by subjects who did not have preoperative ocular pathology, abnormal corneas, or postoperative macular degeneration (Best Case) and visual acuity achieved by overall subject population and by method of cataract extraction as shown...

THREE YEAR DATA Table 8 Visual Acuity By Extraction Method at Three Years Planned Extracapsular Cataract Extraction Age <60 60-69 70-79 >79 Overall ECCE Table 8A Visual Acuity By Extraction Method at Three Years Phacoemulsification Cataract Extraction Age <60 60-69 70-79 >79 Overall Phaco Total Three Year Visual Acuity Data N = 508 COMPLICATIONS The United States Food and Drug Administration has identified eleven (11) potentially sight-threatening complications which may occur following cataract extraction and/or intraocular lens implantation. The cumulative and persistent (present at the one...

Table 10 Cumulative Postoperative Complications at Three Years ECCE N = 24 N NA NA 1 3 0 NA 0 NA 0 0 0 Corneal Edema Iritis Hyphema Macular Edema Pupillary Block Secondary Glaucoma Cyclitic Membrane Vitritis Endophthalmitis Retinal Detachment Lens Dislocation Corneal Edema Iritis Hyphema Macular Edema Pupillary Block Secondary Glaucoma Cyclitic Membrane Vitritis Endophthalmitis Retinal Detachment Lens Dislocation Fifty-four (4.4%) patients receiving the AcrySof® IOL Model MA60BM posterior chamber lens experienced one or more of the complications listed in the previous tables. However, the majority...

Hypopyon Intraocular Infection Acute Corneal Decompensation Secondary Surgical Intervention: a) Lens Replacement/ Removal b) Retinal Detachment Repair c) Repositioning of Lens d) Vitrectomy e) Iridectomy f) Wound Repair Leak g) Photocoagulation h) Removal of Residual Cortex Material i) Anterior Capsulotomy SUPPLEMENTAL PUBLISHED DATA A prospective, well-controlled and randomized study (Ursell et al, 1998; Hollick et al. #1. 1998) with AcrySof® lenses utilizing a uniquely-developed coaxial illumination method linked to a novel computerized digital imaging system (Pande et al, 1998) was conducted...