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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm June 17, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on January 04, 2005
Recall Number Z-1037-04
Recall Event ID 29384
PMA Number P990013 
Product Classification Intraocular Lens - Product Code HQL
Product STAAR Surgical Intra Occular Lens, Collamer.
Code Information All lenses packaged weeks of 9-13 and 23-27 February.
Recalling Firm/
Staar Surgical Co Inc
1911 Walker Ave
Monrovia CA 91016-4846
For Additional Information Contact Janice Filippelli
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
Action Consignees are being notified to check their inventory for mismatching labels. Notifications were sent June 17 to all customers.
Quantity in Commerce Not specified.
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 = HQL and Original Applicant = STARR SURGICAL CO.