Volk Optical

4 recalls •

🏥 Medical Devices

• Categories: Diagnostic Equipment, Other Medical Devices

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

Class I - Dangerous

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

Feb 2, 2016 Diagnostic Equipment View Details →

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

Class I - Dangerous

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.

Feb 27, 2015 Other Medical Devices View Details →

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.

Class I - Dangerous

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

Feb 27, 2015 Other Medical Devices View Details →

20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

Class I - Dangerous

The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205).

Oct 25, 2012 Other Medical Devices View Details →