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U.S. Department of Health and Human Services

Class 3 Device Recall Amvisc

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  Class 3 Device Recall Amvisc see related information
Date Initiated by Firm October 08, 2003
Date Posted November 13, 2003
Recall Status1 Terminated 3 on August 09, 2004
Recall Number Z-0110-04
Recall Event ID 27457
PMA Number P810025 
Product Classification unknown device name - Product Code LZP
Product Amvisc Sodium Hyaluronate 0.8 mL 12 mg/mL Syringe. Sterile. RX. For intraocular use.
Product Number: 780A
Manufactured for Bausch & Lomb Surgical Inc., Irvin, CA
Code Information Lot Numbers: B0201222, B020122D, B020122G
Recalling Firm/
Anika Therapeutics
240 West Cummings Park
Woburn MA 01801
For Additional Information Contact Julie Broderick
781-932-6616 Ext. 107
Manufacturer Reason
for Recall
Stability failure at the 20 month for viscosity specification
FDA Determined
Cause 2
Action Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their customers.
Quantity in Commerce 15, 187 units
Distribution CA, MO, NC,VA

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.