Volk Optical Recalls 20 Diopter Binocular Indirect Ophthalmoscope Lenses
Volk Optical Inc is recalling 40 units of 20 Diopter Binocular Indirect Ophthalmoscope lenses due to mixed-up lot number engravings on the devices and packaging.
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 and packaging labeling error (mis-engraving) rather than a functional defect or contamination.
Plain-English summary
Volk Optical Inc is recalling 40 units of the 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens, product code V20LC. The recall involves devices with lot numbers BB09213 and BB09205. These lenses are used for visualization during diagnosis and laser therapy of the human retina.
The recall was initiated due to a defect involving the mis-engraving of lot numbers directly on the product and its packaging. Specifically, the device engraving for the V20LC (lot # BB09213) was mixed up with that from the V60C (lot # BB09205). This labeling error affects the traceability of the specific devices.
The affected devices were distributed worldwide, including in the United States (specifically in Arizona, California, Georgia, Minnesota, New Jersey, and New Mexico) and internationally to Japan. Consumers and healthcare providers should stop using these specific lenses and contact Volk Optical Inc for further instructions or replacement.
The recalled product
- Product
- 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
- Manufacturer
- Volk Optical Inc
- Hazard
- Affected units
- 40
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)
- Product Code: V20LC
- Lot/Serial Numbers: BB09213 & BB09205
Distribution
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