Volk Optical Recalls 25D BIO Lenses Due to Incorrect Lot Number
Volk Optical Inc. is recalling six 25D Large Clear BIO Lenses because the incorrect lot number was engraved on the anodized aluminum ring.
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 by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling error (incorrect lot number) with no reported injuries or illnesses.
Plain-English summary
Volk Optical Inc. is recalling six units of the Volk 25D Large Clear BIO Lens with case (Model #V25LC, Lot: BE09243). These lenses are intended for visualization during diagnosis and laser therapy of the human retina using a binocular indirect ophthalmoscope.
The recall was initiated due to a mislabeling issue where the incorrect lot number was engraved on the anodized aluminum ring. The affected units were distributed worldwide, including to the United States (Massachusetts and Virginia), Mexico, and Sweden.
Consumers and healthcare providers with these specific lenses should stop using them and contact Volk Optical Inc. for instructions on return or replacement.
The recalled product
- Product
- Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
- Manufacturer
- Volk Optical Inc
- Hazard
- Affected units
- 6
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 #V25LC
- Lot: BE09243
Distribution
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