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 | The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205). |
| 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. |
| Quantity | 40 devices |
| Distribution | Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan. |
| Initiated | 2012-10-25 |
| Classified | 2013-03-18 |
| Terminated | 2013-06-11 |
| Recall number | Z-0966-2013 |
| 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-0966-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64410/
Alerts for VOLK OPTICAL INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.