Volk Optical product recalled over labeling errors

Recall date

February 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Volk Optical Inc recalls Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intende…

Recall number

Z-1685-2015

FDA classification

Class III

Brand / firm

Volk Optical Inc

Sold / distributed

Worldwide Distribution - US Distribution to the states of : MA and VA., and to the countries of Mexico and Sweden.

Why it was recalled

Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.