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U.S. Department of Health and Human Services

Class 2 Device Recall AcrySof ReSTOR Intraocular Lens

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  Class 2 Device Recall AcrySof ReSTOR Intraocular Lens see related information
Date Initiated by Firm December 14, 2006
Date Posting Updated 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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