Volk Optical Recalls Lombart 90D Clear Lenses Due to Mislabeling
Volk Optical Inc is recalling 78 units of the Lombart 90D Clear lens due to an incorrect lot number engraved on the 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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issue is a documentation/labeling error rather than a functional defect.
Plain-English summary
Volk Optical Inc is recalling 78 units of the Lombart 90D Clear lens, model L90C. These lenses are used for visualization during diagnosis and laser therapy of the human retina using a slit lamp. The recall is limited to units distributed to the Department of Veterans Affairs (VA).
The recall was initiated due to a mislabeling error. The correct lot number, BE03356, was not engraved on the anodized aluminum ring. Instead, the incorrect lot number, BD03356, was engraved in error. This discrepancy affects the traceability of the specific product units.
The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Consumers or healthcare providers with these specific units should contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
- Manufacturer
- Volk Optical Inc
- Hazard
- Affected units
- 78
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: L90C
- Lot: BE03356
Distribution
Distributed in 1 state:
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