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 Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit…

Recall number

Z-2055-2015

FDA classification

Class III

Brand / firm

Volk Optical Inc

Sold / distributed

Distribution to VA only

Why it was recalled

Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.

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

What was recalled

Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.