Device recall
Z-3266-2018: Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior…
FDA device recall · Class II · Bausch & Lomb Inc
Key facts
| Recall number (Z-number) | Z-3266-2018 |
|---|---|
| Recall event | 80837 |
| Product | Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper. |
| Product code | HQE |
| Recalling firm | Bausch & Lomb Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2019 |
| 510(k) numbers | K162342 |
| FEI number | 1920664 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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