Volk Optical Inc: Medical Device Recall in 2013 - (Recall #: Z-0966-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: October 25, 2012

Date Posted: March 27, 2013

Recall Number: Z-0966-2013

Event ID: 64410

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).

Status: Terminated

Product Quantity: 40 devices

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated