Device recall
Z-1683-2015: Catalys Precision Laser System-Catalys - U - US product; Catalys-1…
FDA device recall · Class II · Optimedica Corporation
Key facts
| Recall number (Z-number) | Z-1683-2015 |
|---|---|
| Recall event | 70672 |
| Product | Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. |
| Product code | OOE |
| Recalling firm | Optimedica Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 8, 2015 |
| 510(k) numbers | K141079 |
| FEI number | 3005675890 |
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