Class 2 Device Recall Cytosol Opthalmics

• Date Initiated by Firm: July 14, 2005
• Date Posted: August 23, 2005
• Recall Status: Terminated on May 02, 2006
• Recall Number: Z-1383-05
• Recall Event ID: 32711
• PMA Number: P000046
• Product Classification: Aid, Surgical, Viscoelastic - Product Code LZP
• Product: ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC
• Code Information: Lot Numbers: B041118E, B041118F, B050510C
• Recalling Firm/ Manufacturer: Anika Therapeutics, Inc.; 236 W Cummings Park; Woburn MA 01801-6346
• For Additional Information Contact: Tim Mayhew; 781-932-6616 Ext. 142
• Manufacturer Reason for Recall: Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
• FDA Determined Cause: Other
• Action: Anika Therapeutics notified Distributor accounts by telephone on July 14. The letters were faxed and sent by Fedex on July 14. Distributors were provided with a end-user letter template letter for notification to their accounts.
• Quantity in Commerce: 3720 units
• Distribution: CA, NC
• 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