Device recall
Z-1685-2015: Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC…
FDA device recall · Class III · Volk Optical Inc
Key facts
| Recall number (Z-number) | Z-1685-2015 |
|---|---|
| Recall event | 71014 |
| Product | Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope. |
| Product code | HJK |
| Recalling firm | Volk Optical Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 19, 2016 |
| 510(k) numbers | K023221 |
| FEI number | 1000122772 |
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