FDA Device recall Z-1685-2015
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…
- FDA Device
- Class III
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class III recall of 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… by Volk Optical, citing mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1685-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-02-27 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Volk Optical |
| Distribution | MA, VA |
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.
Reason
Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
Identifiers
| upc | 811608010106 |
|---|---|
| code_info | Model #V25LC, Lot: BE09243 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1685-2015%22
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