Home / Recalls / Volk Optical Inc / Z-0966-2013

Z-0966-2013 Class III Terminated

Recalled by Volk Optical Inc — Mentor, OH

Recall Details

Product Type
Devices
Report Date
March 27, 2013
Initiation Date
October 25, 2012
Termination Date
June 11, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40 devices

Product Description

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

Reason for Recall

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).

Distribution Pattern

Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan.

Code Information

Product Code: V20LC; Lot/Serial Numbers: BB09213 & BB09205

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-1685-2015 Class III — Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. (February 27, 2015)