Class III — Volk Optical Inc
| Recalling firm | VOLK OPTICAL INC. |
|---|---|
| Registered facility | VOLK OPTICAL INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error. |
| Product | Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp. |
| Quantity | 78 units |
| Distribution | Distribution to VA only |
| Initiated | 2015-02-27 |
| Classified | 2015-07-09 |
| Terminated | 2016-02-04 |
| Recall number | Z-2055-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Volk Optical Inc (Z-2055-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71048/
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