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Terminated

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

FDA Recall Z-1382-05 · Posted 2005-08-23

Recalling FirmAnika Therapeutics, Inc.
Recall StatusTerminated
Product CodeLZP
Date Initiated2005-07-14
Date Terminated2006-05-02
Product Quantity20,549 units

Reason for Recall

Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.

Firm 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.

Root Cause

Other

Distribution Pattern

CA, NC

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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