Date Initiated by Firm | October 08, 2003 |
Date Posted | November 13, 2003 |
Recall Status1 |
Terminated 3 on August 09, 2004 |
Recall Number | Z-0113-04 |
Recall Event ID |
27457 |
PMA Number | P810025 |
Product Classification |
Aid, Surgical, Viscoelastic - Product Code LZP
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Product | Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml
For European Distribution
Manufactured for Bausch & Lomb Surgical,Irvine,CA and |
Code Information |
Lot Numbers: B020122C, B020122F |
Recalling Firm/ Manufacturer |
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 | Other |
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 | 6036 units |
Distribution | CA, MO, NC,VA |
Total Product Life Cycle | TPLC Device Report |
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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.
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PMA Database | PMAs with Product Code = LZP
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