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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 09, 2004
Date Posted February 18, 2004
Recall Status1 Terminated 3 on January 04, 2005
Recall Number Z-0539-04
Recall Event ID 28264
PMA Number P990013 
Product Classification Intraocular Lens - Product Code HQL
Product Collamer UV One-Piece IntraOcular Lens.

Models 4205BF and 4204BF
Code Information No codes apply
Recalling Firm/
Manufacturer		 Staar Surgical Co Inc
1911 Walker Ave
Monrovia CA 91016-4846
For Additional Information Contact Janice L. Filippelli
626-303-7902
Manufacturer Reason
for Recall		 Risk of hyperopic refractive changes.
FDA Determined
Cause 2		 Other
Action Firm is distributing letters to physicians suggesting ways to mitigate the observed contracture of the eye tissues after implantation. Letters will be sent 2/9/2004.
Quantity in Commerce No quantity applies.
Distribution Nationwide and to Australia, Canada, Chile, France, Germany, India, Lebanon, South Africa, Switzerland, United Kingdom.
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.
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