Home / Recalls / Medical Devices
Abbott Medical Optics Inc (AMO) recalls AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ult
Recalled March 20, 2013 · FDA recall Z-0929-2013 · Abbott Medical Optics Inc (AMO)
Hazard
Two production orders of these IOLs that contain mislabeled IOLs. · FDA Class II
Units
155 units
Sold at
Worldwide Distribution - USA Nationwide including the state of OH and the countries of: Germany, Switzerland, Sweden, Italy, China, France, Singapore, UK, Croatia, Hungary, Turkey and Brazil.
Description
Two production orders of these IOLs that contain mislabeled IOLs.
Product
AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.
Manufacturer(s)
Abbott Medical Optics Inc (AMO)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →