Class 3 Device Recall

• Date Initiated by Firm: February 23, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on January 04, 2005
• Recall Number: Z-0766-04
• Recall Event ID: 28570
• Product Classification: Lens, Guide, Intraocular - Product Code KYB
• Product: MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF
• Code Information: Lot 11853090. Sterility Date : 11/18/2003 Expiration Date: 10/31/2006
• 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 Ext. 2345
• Manufacturer Reason for Recall: Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use.
• FDA Determined Cause: Other
• Action: Firm will be sending thier representatives to customers to inspect inventory and arrange return of product.
• Quantity in Commerce: 690 injectors
• 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.