FDA-Device2016-09-28Class II
SENSAR 1-Piece IOL, Model No. AAB00 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.
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.
Sold states
Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
Affected count
1 unit
Manufactured in
1700 E Saint Andrew Pl, Santa Ana, CA, United States
Products
SENSAR 1-Piece IOL, Model No. AAB00 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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2860-2016Don't want to check this manually?
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