FDA Medical Device Recalls (openFDA)
Anika Therapeutics: 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 number
- Z-0109-04
- Recalling firm
- Anika Therapeutics
- 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
- Status
- Terminated
- Initiated
- 2003-10-08
- Posted
- 2003-11-13
- Terminated
- 2004-08-09
- Reason
- Stability failure at the 20 month for viscosity specification
- Root cause
- Other
- Action
- Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their customers.
- Quantity
- 1526 units
- Distribution
- CA, MO, NC,VA
- Lot, serial or model codes
- Lot Number: B020122E
- 510(k) numbers
- not on file
- PMA numbers
- ["P000046"]
- Product code
- LZP
- Firm FEI
- 3007093114
- Firm city
- Woburn
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28