Class 2 Device Recall

• Date Initiated by Firm: February 09, 2004
• Date Posted: February 18, 2004
• Recall Status: Terminated 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
• FEI Number: 2023826
• 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: 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