FDA Device recall Z-0966-2013
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) u…
- FDA Device
- Class III
- terminated
- Published 2013-03-27
On 2013-03-27 the FDA classified a Class III recall of 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) u… by Volk Optical, citing 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).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0966-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-10-25 |
| Published | 2013-03-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Volk Optical |
| Distribution | AZ, CA, GA, MN, NJ, NM |
Product
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
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).
Identifiers
| code_info | Product Code: V20LC; Lot/Serial Numbers: BB09213 & BB09205 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0966-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.