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January 1987

Closed-Loop Anterior Chamber Lenses

Author Affiliations

Washington, DC
Portland, Ore

Arch Ophthalmol. 1987;105(1):20-21. doi:10.1001/archopht.1987.01060010021004

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To the Editor.  —On Oct 20,1986, data were presented to the Ophthalmic Devices Panel of the Food and Drug Administration (FDA) that indicated a potential for serious lateonset complications caused by closed-loop flexible and semiflexible anterior chamber intraocular lenses (IOLs). Examples of these lenses include the Azar-91Z (IOLAB Corp voluntarily withdrew this lens from the market in 1983), Leiske (Surgidev Corp), Stableflex (Optical Radiation Corp), and other Leiske-type IOLs. Presentations that were made by Drs Kraff, Apple, Kelman, Bodner, and Stark suggested that a disproportionate number of explantations were occurring and that patients with these lenses had been noted to experience a high rate of postoperative corneal edema, uveitis, and cystoid macular edema.Based on the data presented, the Ophthalmic Devices Panel recommended to the Commissioner of the FDA that implantation of these lenses be done only as part of a core investigation and that they should not be available

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