Device recall
Z-1515-2015: OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and…
FDA device recall · Class II · Abbott Medical Optics, Inc.
Key facts
| Recall number (Z-number) | Z-1515-2015 |
|---|---|
| Recall event | 70679 |
| Product | OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens. |
| Product code | OOE |
| Recalling firm | Abbott Medical Optics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 9, 2019 |
| 510(k) numbers | K141079 |
| FEI number | 3006695864 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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