FDAAugust 26, 2016device
SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e 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.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
abbott medical optics inc amoabbottabbott medical
Recall history
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