Reported Jun 3, 2015 · Terminated

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

Volk Optical Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Volk Optical Inc · 7893 Enterprise Dr · Mentor, OH · 44060-5309

Is this the product you have?

  • Volk 25D
  • Large Clear BIO Lens with case UPC8 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
Lot codes and dates
  • Model #V25LC
  • LotBE09243
Amount recalled
6 units

Where it was sold

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 19, 2016 · Data as of Sep 19, 5:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.