Class 3 Device Recall

• Date Initiated by Firm: June 17, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated 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/ Manufacturer: Staar Surgical Co Inc; 1911 Walker Ave; Monrovia CA 91016-4846
• For Additional Information Contact: Janice Filippelli; 626-303-7902
• 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: Other
• 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