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U.S. Department of Health and Human Services

Class 2 Device Recall TECNIS

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  Class 2 Device Recall TECNIS see related information
Date Initiated by Firm August 26, 2016
Date Posted September 21, 2016
Recall Status1 Terminated 3 on December 23, 2016
Recall Number Z-2862-2016
Recall Event ID 75051
PMA Number P980040 
Product Classification intraocular lens - Product Code HQL
Product TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery
System, Model No. PCB00V
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
Code Information Serial No. 5860621403 5860631403 5860641403 5860651403 5860661403 5860671403 5860681403 5860691403 5860701403 5860711403 5860721403 5860731403 5860741403 5860751403 5860771403 5860781403 5860791403 5860801403 5860811403 5860821403 5860831403 5860851403 5860871403 5860881403 5860891403 5860901403 5860911403 5860921403 5860931403 5860941403 5860951403 5860961403 5860971403 5860981403 5860991403 5861001403 5861011403 5861021403 5861031403 5861041403 5861051403 5861061403 5861081403 5861091403 5861101403 5861111403 5861391403 5861401403 5861411403 5861421403 5861431403 5861441403 5861451403 5861461403 5861471403 5861481403 5861491403 5861501403 5861511403 5861521403 5861531403 5861541403 5861551403 5861561403 5861581403 5861591403 5861601403 5861611403 5861621403 5861631403 
Recalling Firm/
Manufacturer		 Abbott Medical Optics Inc. (AMO)
1700 E Saint Andrew Pl
Santa Ana CA 92705-4933
For Additional Information Contact
714-247-8200
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
Action Abbott Medical Optics, Inc. sent an Urgent Field Safety Notice to all affected customers to inform them that Abbott Medical Optics (AMO) is recalling 737 IOLs due to detection of an inspection equipment malfunction that resulted in a total of 737 distributed lenses not being fully checked prior to release. The letter informs customers that this malfunction may result in the release of mislabeled IOLs. The letter informs the customers of the actions to be taken. Customers are instructed to complete Customer Reply Form and fax it to AMO Quality Assurance at 714-247-4510 or email to RegCompliOne@abbott.com. Customers with any questions related to the IOL return process are instructed to contact an AMO Customer Service Representative at 877-266-4543. Customers with product complaints or adverse events are instructed to inform AMO by calling 877-266-4543.
Quantity in Commerce 70 units
Distribution Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
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.
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