Class 2 Device Recall

• Date Initiated by Firm: July 18, 2005
• Date Posted: August 06, 2005
• Recall Status: Terminated on July 25, 2012
• Recall Number: Z-1106-05
• Recall Event ID: 32798
• PMA Number: P000046
• Product Classification: Aid, Surgical, Viscoelastic - Product Code LZP
• Product: Staarvisic II Sodium Hyaluronate, 0.8 mL
• Code Information: Lot B041118C Exp Date 12/31/2005
• FEI Number: 2023826
• Recalling Firm/ Manufacturer: Staar Surgical Co Inc; 1911 Walker Ave; Monrovia CA 91016-4846
• For Additional Information Contact: Valerie Cimmarusti; 626-303-7902
• Manufacturer Reason for Recall: Sterility may be compromised.
• FDA Determined Cause: Other
• Action: Recall will be communicated by telephone, email and letter. A fax back form will be used to track response and to identify ammount on hand.
• Quantity in Commerce: 16,464
• Distribution: Nationwide, Canada and Puerto Rico
• 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 = LZP