Recall Z-1597-2010 ยท HNN Knife, Ophthalmic
Becton Dickinson and Company
BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA. Intended for use in cataract surgery to create self-sealing stab incisions through the cornea or sclera. Also used in retinal surgery for sclerotomy incisions.
| Date | May 13, 2010 (initiated Apr 6, 2010) |
| Status | Terminated |
| Reason | A field action was initiated due to a recent customer complaint from Japan there is a labeling mixup and that some of the BD Visitec EdgeAhead MVR Knife 0.90mm (20G), REF 585230, shelf packs may contain BD Visitec EdgeAhead Slit Knife 2.3mm (40 degree), REF 8009918. |
| Root cause | Packaging process control |
| Action | BD Medical issued a "Voluntary Advisory Notice" dated April 6, 2010. Consignees were informed of the affected product and asked to complete the enclosed Customer Response Form indicating whether the product will be returned to the firm. For further information, contact BD Medical Opthalmic Systems at 1-781-906-7952 or via email at ahusebo@bd.com. |
| Quantity | 1170 (US 810, OUS 360) |
| Distribution | Worldwide Distribution -- United States, Canada and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.