Device recall
Z-1075-2018: Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO) The LIO is a…
FDA device recall · Class II · Iridex Corporation
Key facts
| Recall number (Z-number) | Z-1075-2018 |
|---|---|
| Recall event | 79386 |
| Product | Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate… |
| Product code | GEX |
| Recalling firm | Iridex Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 22, 2023 |
| 510(k) numbers | K170718 |
| FEI number | 2939653 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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