Abbott Medical Optics Inc. (AMO) recalls TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in a

Recalled September 28, 2016 · FDA recall Z-2858-2016 · 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

65 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 1-Piece IOL, Model No. ZCB00 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 →