Device recall
Z-1597-2010: BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA. Intended for…
FDA device recall · Class III · Becton Dickinson and Company
Key facts
| Recall number (Z-number) | Z-1597-2010 |
|---|---|
| Recall event | 55254 |
| Product | 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. |
| Product code | HNN |
| Recalling firm | Becton Dickinson and Company |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 6, 2012 |
| FEI number | 1211998 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database