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U.S. Department of Health and Human Services

Class 2 Device Recall Cytosol Opthalmics

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  Class 2 Device Recall Cytosol Opthalmics see related information
Date Initiated by Firm July 14, 2005
Date Posted August 23, 2005
Recall Status1 Terminated 3 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/
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 2
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 and Original Applicant = Anika Therapeutics, Inc.