Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe.… recallZ-0109-04 · Anika Therapeutics · initiated Oct 8, 2003
Terminated All recalls posted in November 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Anika Therapeutics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Stability failure at the 20 month for viscosity specification
FDA root cause category: Other
What the company is doing
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their customers.
Recall details
- Recall number
- Z-0109-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 8, 2003
- Posted by the FDA
- Nov 13, 2003
- Recalling firm
- Anika Therapeutics
- Quantity
- 1526 units
- Product code
- LZP
- FDA submissions
- P000046
- Distribution
- CA, MO, NC,VA
Product description
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
Code information (models, lots, serial numbers)
Lot Number: B020122E
Other devices under the same FDA submission
2 devices cleared under P000046 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NuVisc 600-108Anika Therapeutics, Inc. · Aid, Surgical, Viscoelastic3 reports
- Anikavisc 600-106Anika Therapeutics, Inc. · Aid, Surgical, Viscoelastic2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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