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
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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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