CLASS III Device recall · Reported 23 Mar 2016 · FDA Enforcement Report
Volk G-4 Small Ring, No Flange, Gonio Lens with case recalled
Volk Optical is recalling Volk G-4 Small Ring, No Flange, Gonio Lens with case, distributed nationwide in the US. The recall was initiated on 2 Feb 2016 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1177-2016
- FDA event ID
- 73213
- Recalling firm
- Volk Optical, Mentor, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Feb 2016
- FDA classified
- 15 Mar 2016
- Reported
- 23 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Feb 2016 | Recall initiated by company | |
| 15 Mar 2016 | Classified by FDA | +42 days |
| 23 Mar 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm discovered that the incorrect lot number was engraved on the product.
Product as listed by the FDA
Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities
Where it was distributed
Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.
Questions about this recall
Is Volk G-4 Small Ring, No Flange, Gonio Lens with case recalled?
Yes. Volk Optical recalled Volk G-4 Small Ring, No Flange, Gonio Lens with case on 2 Feb 2016. The recall is Class III and its status is Terminated. Recall number Z-1177-2016.
Why was it recalled?
The firm discovered that the incorrect lot number was engraved on the product.
Which lots are affected?
Model #: VG4SNF, Lot: BE05200
Where was it sold?
Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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