Device 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.
Z-0966-2013
Product summary
- Firm
- Volk Optical Inc
- Event
- Event 64410
- Status
- Terminated
- Classification
- Class III
- Quantity
- 40 devices
- Official record key
device-enforcement:Z-0966-2013
Official wording
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).
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.
Derived failure modes
-
Unknown
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).