Device recall
Z-0593-2013: Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module…
FDA device recall · Class II · Bausch & Lomb Inc
Key facts
| Recall number (Z-number) | Z-0593-2013 |
|---|---|
| Recall event | 63057 |
| Product | Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy. |
| Product code | HQC |
| Recalling firm | Bausch & Lomb Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2013 |
| 510(k) numbers | K101325 |
| FEI number | 1317628 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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