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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 Recall
AcrySof ReSTOR Intraocular Lens
see related information
Date Posted February 15, 2007
Recall Status1 Terminated on April 09, 2008
Recall Number Z-0430-2007
Recall Event ID 37009
Premarket Approval
PMA Numbers
P040020 P930014
Product Classification Lens, Multifocal Intraocular - 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, Texas 76134-2001
Manufacturer Reason
for Recall
Intraocular lenses exposed to extreme temperatures while in storage.
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 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 Applicant = ALCON LABORATORIES, INC.
PMAs with Product Code = MFK and Applicant = ALCON RESEARCH, LTD.
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