Device recall
Z-0966-2013: 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during…
FDA device recall · Class III · Volk Optical Inc
Key facts
| Recall number (Z-number) | Z-0966-2013 |
|---|---|
| Recall event | 64410 |
| Product | 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope. |
| Product code | HJL |
| Recalling firm | Volk Optical Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 11, 2013 |
| FEI number | 1000122772 |
At a glance
- None 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