Date Initiated by Firm | August 26, 2016 |
Date Posted | September 21, 2016 |
Recall Status1 |
Terminated 3 on December 23, 2016 |
Recall Number | Z-2864-2016 |
Recall Event ID |
75051 |
PMA Number | P880081 |
Product Classification |
intraocular lens - Product Code HQL
|
Product | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002
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. 1104621505 1164491602 1164501602 1164511602 1164521602 1164541602 1164551602 1164561602 1164571602 1164581602 1164601602 1164611602 1164621602 1164641602 1164651602 1164711602 1074911602 1074921602 1074931602 1074941602 1074951602 1074961602 1074971602 1074981602 1074991602 1075001602 1075011602 1075021602 1075031602 1075041602 1075051602 1075061602 1075071602 1075081602 1075091602 1075101602 1075111602 1075131602 1075141602 1075151602 1075121602 |
Recalling Firm/ Manufacturer |
Abbott Medical Optics Inc. (AMO) 1700 E Saint Andrew Pl Santa Ana CA 92705-4933
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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 | 41 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 |
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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.
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PMA Database | PMAs with Product Code = HQL
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