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Abbott Medical Optics Inc. (AMO) recalls TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visu
Recalled September 28, 2016 · FDA recall Z-2859-2016 · 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
131 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 OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. 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 →