TECNIS IOL with the TECNIS iTec Preloaded Delivery System recalled over labeling errors

Recall date

August 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Abbott Medical Optics Inc. (AMO) recalls TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implant…

Recall number

Z-2861-2016

FDA classification

Class II

Brand / firm

Abbott Medical Optics Inc. (AMO)

Sold / distributed

Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 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.