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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmJune 17, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on January 04, 2005
Recall NumberZ-1037-04
Recall Event ID 29384
PMA NumberP990013 
Product Classification Intraocular Lens - Product Code HQL
ProductSTAAR Surgical Intra Occular Lens, Collamer.
Code Information All lenses packaged weeks of 9-13 and 23-27 February.
FEI Number 2023826
Recalling Firm/
Manufacturer		 Staar Surgical Co Inc
1911 Walker Ave
Monrovia CA 91016-4846
For Additional Information ContactJanice Filippelli
626-303-7902
Manufacturer Reason
for Recall		Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number.
FDA Determined
Cause 2		Other
ActionConsignees are being notified to check their inventory for mismatching labels. Notifications were sent June 17 to all customers.
Quantity in CommerceNot specified.
DistributionNationwide.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = HQL
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