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-0276-2012
• Recall Event ID: 59980
• PMA Number: P980040
• Product Classification: Intraocular lens - Product Code HQL
• Product: Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 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: 5058981009 5059401009 5059831009 5058991009 5059411009 5059841009 5059001009 5059421009 5059851009 5059011009 5059431009 5059861009 5059021009 5059441009 5059871009 5059031009 5059451009 5059881009 5059041009 5059461009 5059891009 5059051009 5059471009 5059901009 5059061009 5059481009 5059911009 5059071009 5059491009 5059921009 5059081009 5059501009 5059931009 5059091009 5059511009 5059941009 5059101009 5059521009 5059111009 5059531009 5059121009 5059541009 5059131009 5059551009 5059141009 5059561009 5059151009 5059571009 5059161009 5059581009 5059171009 5059591009 5059181009 5059601009 5059191009 5059611009 5059201009 5059621009 5059211009 5059631009 5059221009 5059641009 5059231009 5059651009 5059241009 5059661009 5059251009 5059671009 5059261009 5059681009 5059271009 5059691009 5059281009 5059701009 5059291009 5059711009 5059301009 5059721009 5059311009 5059731009 5059321009 5059741009 5059331009 5059761009 5059341009 5059771009 5059351009 5059781009 5059361009 5059791009 5059371009 5059801009 5059381009 5059811009 5059391009 5059821009
• 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: 96
• 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