10-500-073-008 0123 PRODUCT INFORMATION Alcon Laboratories, Inc. STERILE UV-Absorbing PMMA Single-Piece Posterior Chamber Lenses

PRODUCT INFORMATION Alcon Laboratories, Inc. STERILE UV-Absorbing PMMA Single-Piece 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 Hole Locations Haptic Type Haptic Angle/ Conguration Eyelets None None None None None None None Mod-C Mod-C Mod-C Mod-C Mod-C Mod-C Mod-C Mod-C † For implantation in the capsular bag (see INDICATIONS) SLANT™1 Haptics Certain models listed above are footnoted as having “SLANT™1” haptics. The following diagrams compare this haptic conguration with common...

SPECTRAL TRANSMITTANCE CURVES (PERCENTAGE OF ULTRAVIOLET TRANSMITTANCE) Figure 2 100 90 TRANSMITTANCE (%) NOTES: • The cutoff wavelength and the spectral transmittance curves presented here represent the range of transmittance values of IOLs made from ultraviolet-absorbing PMMA. • Measurements were direct transmittance using a disc of thickness equivalent to the optic center. • UV cutoff at 10% T is 374 nm (-10.0 diopter lens). UV cutoff at 10% T is 388 nm (+34.0 diopter lens). • Human lens data from Boettner and Wolter (1962). MODE OF ACTION These posterior chamber intraocular lenses are intended...

The long-term effects of intraocular lens implants have not been determined. Therefore, physicians should continue to monitor patients postoperatively on a regular basis. Patients with preoperative problems such as corneal endothelial disease, abnormal cornea, macular degeneration, glaucoma, and chronic drug miosis may not achieve the visual acuity of patients without such problems. The physician must determine the benets to be derived from lens implantation when such conditions exist. Patients who experience surgical complications associated with the cataract extraction procedure (posterior...

This information is being requested from all surgeons in order to document potential long-term effects of intraocular lens implantation. Surgeons should use the following address and telephone number for reporting adverse events involving these lenses: Alcon Laboratories, Inc., Medical Safety (AB 2-6), 6201 South Freeway, Fort Worth, Texas 76134-2099. Call Collect: (817) 551-4445. Outside the United States, contact local Alcon ofces or distributors regarding reports of adverse events. CLINICAL STUDIES Models CR-1, GR-1, and SM-1 - The clinical results achieved by 504 cohort patients who were...

Cumulative Incidence % Cumulative Incidence % Hyphema Macular Edema Pupillary Block Secondary Glaucoma Cyclitic Membrane Vitritis Endophthalmitis Retinal Detachment Corneal Edema Iritis Lens Dislocation Fifty-one (10.1%) cohort patients receiving the non-UV-absorbing lenses (CR-1, GR-1, SM-1) experienced one or more of the above complications. However, these complications occurred early in the postoperative time frame and appear to be associated with the cataract extraction. Ten patients (2.0%) were reported to have these complications 12-14 months after surgery. Ninetyone (17.9%) cohort patients...

SYMBOLS USED ON LABELING SYMBOL PMMA IOL PC PCL B C M P R UV D ENGLISH Polymethylmethacrylate Intraocular lens Posterior chamber Posterior chamber lens Biconvex Convexoplano Meniscus Plano-concave Ridged Ultraviolet Diopter 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. Willis, D.A., et al. Pupillary block associated with 16(2):108-109, 1985. Body diameter (Optic diameter) Overall diameter (Overall...