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U.S. Department of Health and Human Services

Class 2 Device Recall TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811

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  Class 2 Device Recall TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811 see related information
Date Initiated by Firm September 29, 2015
Date Posted November 06, 2015
Recall Status1 Terminated 3 on December 03, 2015
Recall Number Z-0237-2016
Recall Event ID 72434
Product Classification intraocular lens - Product Code HQL
Product TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
Code Information SN: U07310001 thru U07310040 , 07310050 thru U07310059
Recalling Firm/
Manufacturer		 Tekia, Inc.
17 Hammond Ste 414
Irvine CA 92618-1635
For Additional Information Contact
949-699-1300
Manufacturer Reason
for Recall		 Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.
FDA Determined
Cause 2		 Error in labeling
Action Tekia sent an Field Safety Notice dated September 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were advised that Tekia is recalling a limited a number of Single Piece Hydrophilic Acrylic IOLs. If the customer has any questions, the customer is instructed to contact a TEKIA Customer Service or QA Representative at (949) 699-1300. Customers with product complaints or adverse events regarding the use of Single Piece Hydrophilic Acrylic IOLs are instructed to inform TEKIA by phone, email, or fax.
Quantity in Commerce 50 units
Distribution Internationally to Vietnam.
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.
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