Class 3 Device Recall

• Date Initiated by Firm: April 21, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated 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
• 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: Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector.
• FDA Determined Cause: 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