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U.S. Department of Health and Human Services

Class 2 Device Recall Sensar Foldable IOL with OptiEdge

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 Class 2 Recall
Sensar Foldable IOL with OptiEdge
see related information
Date Posted March 09, 2013
Recall Status1 Terminated on January 08, 2014
Recall Number Z-0929-2013
Recall Event ID 64015
Premarket Approval
PMA Number
P980040
Product Classification Intraocular Lens - Product Code HQL
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.
Code Information Diopter 18.0 4760271207 4760661207 4761191207 4760281207 4760681207 4761211207 4760291207 4760701207 4761221207 4760301207 4760721207 4761231207 4760311207 4760741207 4761241207 4760321207 4760761207 4761251207 4760331207 4760781207 4761261207 4760341207 4760801207 4761271207 4760351207 4760811207 4761281207 4760361207 4760821207 4760371207 4760841207 4760381207 4760861207 4760391207 4760881207 4760401207 4760901207 4760411207 4760921207 4760421207 4760941207 4760431207 4760961207 4760441207 4760981207 4760451207 4761001207 4760461207 4761031207 4760471207 4761041207 4760481207 4761051207 4760491207 4761061207 4760501207 4761071207 4760511207 4761081207 4760531207 4761091207 4760551207 4761101207 4760571207 4761111207 4760591207 4761121207 4760601207 4761131207 4760611207 4761151207 4760621207 4761161207 4760631207 4761171207 4760641207 4761181207 Diopter 23.5 4759221207 4759821207 4760161207 4759231207 4759831207 4760171207 4759241207 4759841207 4760181207 4759251207 4759851207 4760191207 4759261207 4759861207 4760201207 4759271207 4759871207 4760211207 4759281207 4759881207 4760221207 4759291207 4759891207 4760231207 4759311207 4759901207 4760241207 4759321207 4759911207 4760251207 4759331207 4759921207 4759341207 4759931207 4759361207 4759941207 4759381207 4759951207 4759401207 4759961207 4759421207 4759971207 4759441207 4759981207 4759461207 4759991207 4759481207 4760001207 4759671207 4760011207 4759681207 4760021207 4759691207 4760031207 4759701207 4760041207 4759711207 4760051207 4759721207 4760061207 4759731207 4760071207 4759741207 4760081207 4759751207 4760091207 4759761207 4760101207 4759771207 4760111207 4759781207 4760121207 4759791207 4760131207 4759801207 4760141207 4759811207 4760151207
Recalling Firm/
Manufacturer
Abbott Medical Optics Inc (AMO)
1700 E Saint Andrew Pl
Santa Ana, California 92705-4933
Manufacturer Reason
for Recall
Two production orders of these IOLs that contain mislabeled IOLs.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action AMO sent an Urgent Field Safety Notice letter to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to stop using and remove affected product from inventory. The letter advice customers to complete and return the enclosed Facsimile Form. For questions contact AMO Customer Service Representative.
Quantity in Commerce 155 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = HQL and Applicant = ABBOTT MEDICAL OPTICS INC
PMAs with Product Code = HQL and Applicant = ADVANCED MEDICAL OPTICS, INC.
PMAs with Product Code = HQL and Applicant = ALLERGAN, INC.
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