Recall Z-0110-04 ยท LZP Aid, Surgical, Viscoelastic
Anika Therapeutics
Amvisc Sodium Hyaluronate 0.8 mL 12 mg/mL Syringe. Sterile. RX. For intraocular use. Product Number: 780A Manufactured for Bausch & Lomb Surgical Inc., Irvin, CA
| Date | Nov 13, 2003 (initiated Oct 8, 2003) |
| Status | Terminated |
| 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 | 15, 187 units |
| Distribution | CA, MO, NC,VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.