FDA-Device2016-03-23Class III

Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities

Volk Optical Inc
Hazard

The firm discovered that the incorrect lot number was engraved on the product.

Sold states
Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.
Affected count
9 lens
Manufactured in
7893 Enterprise Dr, Mentor, OH, United States
Products
Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1177-2016

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