Date Initiated by Firm |
December 14, 2006 |
Date Posted |
February 15, 2007 |
Recall Status1 |
Terminated 3 on April 09, 2008 |
Recall Number |
Z-0430-2007 |
Recall Event ID |
37009 |
PMA Number |
P040020 |
Product Classification |
Intraocular Lens - Product Code MFK
|
Product |
AcrySof¿ ReSTOR¿ Intraocular Lens |
Code Information |
Model MN60D3, Serial numbers: 940376.028; 945173.084; 945533.043; 945174.053; 944089.027; 942202.069; 940407.058; 940407.059; 942210.016; and 945537.073 |
Recalling Firm/ Manufacturer |
Alcon Laboratories, Inc 6201 South Fwy Fort Worth TX 76134-2001
|
Manufacturer Reason for Recall |
Intraocular lenses exposed to extreme temperatures while in storage.
|
FDA Determined Cause 2 |
Other |
Action |
The recall of the fifteen re-shipped lenses was conducted by telephone calls to the nine customers that had received the lenses. These calls were made on December 14, 2006. |
Quantity in Commerce |
10 units |
Distribution |
Nationwide. |
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 = MFK and Original Applicant = Alcon Research, Ltd.
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