Home / Recalls / Volk Optical Inc / Z-1685-2015

Z-1685-2015 Class III Terminated

Recalled by Volk Optical Inc — Mentor, OH

Recall Details

Product Type
Devices
Report Date
June 3, 2015
Initiation Date
February 27, 2015
Termination Date
February 19, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

Model #V25LC, Lot: BE09243

Other recalls by Volk Optical Inc

  • Z-1177-2016 Class III — Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use (February 2, 2016)
  • Z-2055-2015 Class III — Lombart 90D Clear with case Visualization during diagnosis and laser therapy of (February 27, 2015)
  • Z-0966-2013 Class III — 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization dur (October 25, 2012)