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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMarch 28, 2005
Date PostedApril 27, 2005
Recall Status1 Terminated 3 on July 11, 2005
Recall NumberZ-0775-05
Recall Event ID 31653
Product Classification Gauze/Sponge, Internal, X-Ray Detectable - Product Code GDY
ProductSTAAR Phaco Tubing Kit
Code Information Lot 08345
FEI Number 2023826
Recalling Firm/
Manufacturer		 Staar Surgical Co Inc
1911 Walker Ave
Monrovia CA 91016-4846
For Additional Information ContactValerie Cimmarusti
626-303-7902 Ext. 2345
Manufacturer Reason
for Recall		Complaints of leaking with question of sterility and risk of infection in eye.
FDA Determined
Cause 2		Other
ActionRecall was conducted by telephone and letter delivered by FEDEX on April 7, 2004. All consignees have been contacted.
Quantity in Commerce114
DistributionCA, NV, UT, FL, OR.
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.
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