Food, drugs, devices › Volk Optical Inc
Device recall: 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the huma
Volk Optical Inc (Mentor, OH) initiated this device recall on 25 Oct 2012; FDA lists 1 product record under event 64410, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 6% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 11 Jun 2013. Initiation: voluntary: firm initiated. Volk Optical Inc has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Volk Optical Inc, Mentor, OH.
Reason for recall
"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)."
Distribution
"Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0966-2013 | 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope. | 40 devices | Class III | Terminated | 27 Mar 2013 |
Context
Other enforcement events for Volk Optical Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Feb 2016 | Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye exa | Device | Class III | 1 |
| 27 Feb 2015 | Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit l | Device | Class III | 1 |
| 27 Feb 2015 | Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended | Device | Class III | 1 |
All 4 events for Volk Optical Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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)."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Jun 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.