Device recall
Z-0863-2018: LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE…
FDA device recall · Class II · Bausch & Lomb Inc Irb
Key facts
| Recall number (Z-number) | Z-0863-2018 |
|---|---|
| Recall event | 76874 |
| Product | LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures. |
| Product code | HNN |
| Recalling firm | Bausch & Lomb Inc Irb |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 25, 2018 |
| FEI number | 1317628 |
At a glance
- None Linked 510(k)s
- 10–99 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