Recall Z-0606-2011 ยท LZP Aid, Surgical, Viscoelastic
Becton Dickinson and Company
Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. Rx For Intraocular Use REF 585304 Use as a surgical aid to protect corneal endothelium during cataract extraction procedures, intraocular lens implantation and anterior segment surgery.
| Date | Dec 16, 2010 (initiated Oct 4, 2010) |
| Status | Terminated |
| Reason | Finger flange on the BD 1% OVD syringe can disengage during cataract surgery and and may lead to injury. |
| Root cause | Component design/selection |
| Action | Beaver Visitec issued an Urgent: Field Safety Notice letter, dated 10/4/10 to direct accounts, identifying the affected product and informing users of the potential for the finger grip to disengage during use. The firm offers solutions as follows: Allow the finger grip to remain attached to the syringe and continue to use the product. Position the open side of the finger grip towards the palm to avoid detachment of the grip from the syringe. Remove the finger grip and continue to use the product. Return the unused product to Beaver-Visitec for reimbursement. Users were requested to complet |
| Quantity | 72278 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.