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Abbott Medical Optics Inc. (AMO) recalls TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation
Recalled September 28, 2016 · FDA recall Z-2863-2016 · Abbott Medical Optics Inc. (AMO)
Hazard
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs. · FDA Class II
Units
41 units
Sold at
Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
Description
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Product
TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag
Manufacturer(s)
Abbott Medical Optics Inc. (AMO)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →