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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 April 21, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 26, 2012
Recall Number Z-0957-04
Recall Event ID 28896
510(K)Number k980696  
Product Classification Lens, Guide, Intraocular - Product Code KYB
Product MicroSTAAR Injector, MSI-PF

Packed ten per box.
Code Information Lot 1186591 Expires 12/31/06 Lot 1186692 Expires 12/31/06
Recalling Firm/
Manufacturer		 Staar Surgical Co Inc
1911 Walker Ave
Monrovia CA 91016-4846
For Additional Information Contact Janice L. Filippelli
626-303-7902 Ext. 2345
Manufacturer Reason
for Recall		 Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector.
FDA Determined
Cause 2		 Other
Action Recall will be implemented by visits by company representatives.
Quantity in Commerce 124 boxes, 10 per box.
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.
510(K) Database 510(K)s with Product Code = KYB and Original Applicant = STAAR SURGICAL CO.
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