Z-0966-2013 Class III Terminated
FDA device recall Z-0966-2013 was initiated by Volk Optical Inc on October 25, 2012 and is designated Class III. 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). The recall status is terminated (terminated June 11, 2013). Affected quantity: 40 devices.
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