Class 2 Device Recall Sensar Foldable IOL with OptiEdge

• Date Initiated by Firm: September 20, 2011
• Date Posted: November 23, 2011
• Recall Status: Terminated on January 08, 2014
• Recall Number: Z-0275-2012
• Recall Event ID: 59980
• PMA Number: P980040
• Product Classification: Intraocular lens - Product Code HQL
• Product: Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter.; ; The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
• Code Information: 5185681009 5186101009 5185691009 5186111009 5185701009 5186121009 5185711009 5186131009 5185721009 5186141009 5185731009 5186151009 5185741009 5186161009 5185751009 5186171009 5185761009 5186181009 5185771009 5186191009 5185781009 5186201009 5185791009 5186211009 5185801009 5186221009 5185811009 5186231009 5185821009 5186241009 5185831009 5186251009 5185841009 5186261009 5185851009 5186271009 5185861009 5186281009 5185871009 5186291009 5185881009 5186301009 5185891009 5186311009 5185901009 5186321009 5185911009 5186331009 5185921009 5186341009 5185931009 5186351009 5185941009 5186361009 5185951009 5186371009 5185961009 5186381009 5185971009 5186391009 5185981009 5186401009 5185991009 5186411009 5186001009 5186421009 5186011009 5186431009 5186021009 5186441009 5186031009 5186451009 5186041009 5186461009 5186051009 5186471009 5186061009 5186491009 5186071009 5186501009 5186081009 5186511009 5186091009
• Recalling Firm/ Manufacturer: Abbott Medical Optics Inc (AMO); 1700 E Saint Andrew Pl; Santa Ana CA 92705-4933
• For Additional Information Contact: 714-247-8656
• Manufacturer Reason for Recall: The firm is initiating this voluntary recall because of the possibility that certain Sensar IOLs are labeled with an incorrect diopter power.
• FDA Determined Cause: Employee error
• Action: Abbott Medical Optics, Inc. sent an URGENT FIELD SAFETY NOTICE dated September 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using and remove the affected product from their inventory, complete and return the included facsimile form to Abbott Medical Optics and indicate the status of each affected serial number on the form. Customers were asked to return the form even if they have no inventory affected by the recall. For any questions customers were instructed to contact their Abbott Medical Optics Customer Service Representative. For any questions regarding this recall call 714-247-8656.
• Quantity in Commerce: 83
• Distribution: Worldwide Distribution including China, India, Indonesia, Korea, Malasyia, Taiwan, Thailand, Austria, Finland, France, Germany, Great Britain, Hungary, Italy, Netherlands, Portugal, and Saudy Arabia
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = HQL and Original Applicant = Johnson & Johnson Surgical Vision, Inc.