Device recall
Z-0864-2015: Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software)…
FDA device recall · Class II · Bausch & Lomb Inc
Key facts
| Recall number (Z-number) | Z-0864-2015 |
|---|---|
| Recall event | 69717 |
| Product | Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the… |
| Product code | HQF |
| Recalling firm | Bausch & Lomb Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2017 |
| 510(k) numbers | K133486 |
| FEI number | 1920664 |
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