Anika Therapeutics Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml For European Distribution Manufactured for Bausch & Lomb Surgical,Irvine,CA and Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml For European Distribution Manufactured for Bausch & Lomb Surgical,Irvine,CA and
Brand
Anika Therapeutics
Lot Codes / Batch Numbers
Lot Numbers: B020122C, B020122F
Products Sold
Lot Numbers: B020122C, B020122F
Anika Therapeutics is recalling Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml For European Distribution Manufactured for due to Stability failure at the 20 month for viscosity specification. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Stability failure at the 20 month for viscosity specification
Recommended Action
Per FDA guidance
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, MO, NC, VA
Page updated: Jan 10, 2026