Device 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.
Z-1685-2015
Product summary
- Firm
- Volk Optical Inc
- Event
- Event 71014
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1685-2015
Official wording
Reason: Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
Code information: Model #V25LC, Lot: BE09243
Distribution pattern: Worldwide Distribution - US Distribution to the states of : MA and VA., and to the countries of Mexico and Sweden.
Derived failure modes
-
Labeling or packaging
Mislabeling