MODEL MN60AC
13Pages

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 ltering 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 ltering...

SPECTRAL TRANSMITTANCE CURVES (PERCENTAGE OF ULTRAVIOLET TRANSMITTANCE) Figure 2 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 ltering 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 for 20.0 D IOLs (%T) Model Transmittance Reduction with MN60AC (% of...

13. Glaucoma 14. Chronic uveitis 15. Diabetic retinopathy 16. Clinically signicant 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...

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 ofces or distributors. DIRECTIONS FOR USE 1. Examine the label on the unopened package for model, power, proper conguration, and expiration date. 2. 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. 3. To remove the lens, open the pouch and transfer the case to a...

Table 2a Best Corrected Visual Acuity in the Best Case Patient Population at a Minimum of One Year Postoperatively, AcrySof® Natural IOL SB30AL Acuity #Per N Table 2b Best Corrected Visual Acuity in the Best Case Patient Population at a Minimum of One Year Postoperatively, AcrySof® IOL SA30AL control Acuity > 20/40 to < 20/80 Table 3a Best Corrected Visual Acuity in the Overall Patient Population at a Minimum of One Year Postoperatively, AcrySof® Natural IOL SB30AL Acuity #Per N

Table 3b Best Corrected Visual Acuity in the Overall Patient Population at a Minimum of One Year Postoperatively, AcrySof® IOL 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 signicant differences between the Model SB30AL and the Model SA30AL for the proportion of subjects experiencing any of...

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 Macular Edema 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 rst operative eye and...

Table 6A Visual Acuity in Best Case Patient Population at Three Years 20/40 or better ONE YEAR DATA Table 7 N=18 Visual Acuity By Extraction Method at One Year Planned Extracapsular Cataract Extraction 20/40 or better Total Reported Table 7A N=1020 Visual Acuity By Extraction Method at One Year Phacoemulsication Cataract Extraction 20/40 or better Grand Total THREE YEAR DATA Table 8 Visual Acuity By Extraction Method at Three Years Planned Extracapsular Cataract Extraction 20/40 or better Age Overall ECCE

Table 8A Visual Acuity By Extraction Method at Three Years Phacoemulsication Cataract Extraction Total Three Year Visual Acuity Data N=508 COMPLICATIONS The United States Food and Drug Administration has identied 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 year visit) rates of these complications during the rst and third postoperative years for the Model MA60BM patients stratied by cataract extraction method is shown in Tables 9, 9A, 10 and 10A....

Table 10 Cumulative Postoperative Complications at Three Years ECCE N=24 Corneal Edema Iritis Hyphema Macular Edema Pupillary Block Secondary Glaucoma Cyclitic Membrane Vitritis Endophthalmitis Retinal Detachment Lens Dislocation Table 10A Persistent Postoperative Complications at Three Years ECCE N=24 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...

Table 11A Adverse Reactions at Three Years Postoperatively ECCE N=24 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...