Anika Therapeutics, Inc. Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. P/N490-001 Distributed by: STAAR Surgical Inc., Monrovia CA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. P/N490-001 Distributed by: STAAR Surgical Inc., Monrovia CA
Brand
Anika Therapeutics, Inc.
Lot Codes / Batch Numbers
Lot Numbers: B041118C, B050510A
Products Sold
Lot Numbers: B041118C, B050510A
Anika Therapeutics, Inc. is recalling Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. P/N490-001 due to Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
Recommended Action
Per FDA guidance
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.
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, NC
Page updated: Jan 10, 2026