FDA-Device2015-06-03Class III
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.
Volk Optical Inc
Hazard
Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
Sold states
Worldwide Distribution - US Distribution to the states of : MA and VA., and to the countries of Mexico and Sweden.
Affected count
6 units
Manufactured in
7893 Enterprise Dr, Mentor, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1685-2015Don't want to check this manually?
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