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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-2858-2016
Recall Event ID 75051
PMA Number P980040 
Product Classification intraocular lens - Product Code HQL
Product TECNIS 1-Piece IOL, Model No. ZCB00
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. 2005271506 5914601206 4651021512 5807371506 4427981206 4427991206 4428001206 4428011206 4428021206 4428031206 4428041206 4428051206 4428061206 4428071206 4428081206 4428091206 4428101206 4428111206 4428121206 4428131206 4428141206 4428151206 4428161206 4428171206 4428181206 4428191206 4428201206 4428211206 4428221206 4428231206 4428241206 4428251206 4428261206 4428271206 4428281206 4428291206 4428311206 4428321206 4428331206 4428341206 4428351206 4428361206 4428371206 4428381206 5152461501 5152471501 5152481501 5152491501 5152501501 5152531501 5152541501 5152551501 5152561501 5152571501 5152581501 5152591501 5152601501 5152611501 5152621501 5152631501 5152641501 5152651501 5152661501 5152671501 4428301206
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 65 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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