ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL.… recallZ-1383-05 · Anika Therapeutics, Inc. · initiated Jul 14, 2005
Terminated All recalls posted in August 2005
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, Inc. 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
Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1383-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 14, 2005
- Posted by the FDA
- Aug 23, 2005
- Recalling firm
- Anika Therapeutics, Inc.
- Quantity
- 3720 units
- Product code
- LZP
- FDA submissions
- P000046
- Distribution
- CA, NC
Product description
ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC
Code information (models, lots, serial numbers)
Lot Numbers: B041118E, B041118F, B050510C
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
Other products in the same recall event
The FDA groups related products into one recall event (event 32711).
- Z-1382-05 · TerminatedStaarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. P/N490-001 Distributed by: STAAR Surgical Inc., Monrovia CA
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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