FDA-Device2013-03-20Class II
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.
Abbott Medical Optics Inc (AMO)
Hazard
Two production orders of these IOLs that contain mislabeled IOLs.
Sold states
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.
Affected count
155 units
Manufactured in
1700 E Saint Andrew Pl, N/A, Santa Ana, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0929-2013Don't want to check this manually?
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