Volk Optical Recalls G-4 Gonio Lenses Due to Incorrect Lot Number
Volk Optical Inc is recalling G-4 Small Ring Gonio Lenses because the incorrect lot number was engraved on the product.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a documentation error (incorrect lot number) with no reported injuries or illnesses.
Plain-English summary
Volk Optical Inc is recalling the Volk G-4 Small Ring, No Flange, Gonio Lens with case (Model #: VG4SNF, Lot: BE05200). The recall was initiated because the firm discovered that the incorrect lot number was engraved on the product.
The affected product is a diagnostic contact lens used for eye examinations and the therapy of intraocular abnormalities. The recall involves 9 lenses. The product was distributed worldwide, specifically to the United States (Virginia only), Canada, France, and Indonesia.
Consumers should stop using the product and contact Volk Optical Inc for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Volk Optical Inc
- Hazard
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model #: VG4SNF
- Lot: BE05200
Distribution
Distributed in 1 state:
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