PRODUCT INFORMATION Alcon Laboratories, Inc. STERILE UV-Absorbing PMMA Single-Piece Posterior Chamber Lenses

Product catalog summary

Product Overview: Alcon Laboratories, Inc. offers sterile UV-absorbing PMMA single-piece posterior chamber lenses for visual correction of aphakia in adults post-cataract surgery. These lenses are made from polymethylmethacrylate (PMMA) and come in various models with different optic types and configurations.

Model Characteristics: The lenses differ in optic diameter, overall length, and haptic configuration. Certain models are designed for implantation in the capsular bag, with SLANT™1 haptics highlighted for specific models.

Optical Properties: The lenses have a UV cutoff at 10% transmittance between 374 nm and 388 nm, depending on the diopter. The index of refraction is 1.49, and they are available in powers from +4.0 to +34.0 diopters.

Indications and Contraindications: These lenses are indicated for adult patients post-cataract surgery but are not recommended for patients under 18 or those with conditions like congenital bilateral cataracts or uncontrolled glaucoma.

Warnings and Precautions: Potential complications include lens dislocation, inflammation, and retinal detachment. The safety in patients with pre-existing ocular conditions is not fully established. Proper surgical skill and preoperative evaluation are essential.

Clinical Studies: Studies show the lenses' safety and effectiveness, with a high percentage of patients achieving 20/40 or better visual acuity postoperatively. Complications are monitored and reported for patient safety.

Patient Registration and Reporting: Post-implantation, patients must register with Alcon Laboratories for long-term follow-up. Adverse events should be reported to Alcon for documentation and analysis.

Complications and Incidence: The document provides data on complications following cataract extraction with intraocular lens implantation. Key complications include hyphema, macular edema, pupillary block, and secondary glaucoma. Complications were more frequent early postoperatively and associated with the cataract extraction process.

Adverse Reactions: Adverse reactions were reported for both non-UV-absorbing and UV-absorbing lens models, with specific rates for hypopyon and secondary surgical interventions.

Product Information: The lenses are supplied dry and sterilized with ethylene oxide. They must be opened under aseptic conditions. The expiration date is marked on the packaging, and expired lenses should be returned to Alcon Laboratories.

Returned Goods Policy: In the U.S., returned lenses are exchanged for other products, not credited. Returns require a Returned Goods Number from Alcon’s Customer Service. Outside the U.S., local Alcon offices handle returns.

Symbols and References: The document includes symbols used in labeling, such as PMMA for polymethylmethacrylate and IOL for intraocular lens, along with references to studies on ocular media transmission and complications.

Catalog excerpts

PRODUCT INFORMATION Alcon Laboratories, Inc. STERILE UV-Absorbing PMMA Single-Piece Posterior Chamber Lenses-1

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

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PRODUCT INFORMATION Alcon Laboratories, Inc. STERILE UV-Absorbing PMMA Single-Piece Posterior Chamber Lenses-2

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...

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PRODUCT INFORMATION Alcon Laboratories, Inc. STERILE UV-Absorbing PMMA Single-Piece Posterior Chamber Lenses-3

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...

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PRODUCT INFORMATION Alcon Laboratories, Inc. STERILE UV-Absorbing PMMA Single-Piece Posterior Chamber Lenses-4

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...

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PRODUCT INFORMATION Alcon Laboratories, Inc. STERILE UV-Absorbing PMMA Single-Piece Posterior Chamber Lenses-5

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...

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PRODUCT INFORMATION Alcon Laboratories, Inc. STERILE UV-Absorbing PMMA Single-Piece Posterior Chamber Lenses-6

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...

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PRODUCT INFORMATION Alcon Laboratories, Inc. STERILE UV-Absorbing PMMA Single-Piece Posterior Chamber Lenses-7

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...

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