Device product
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
Z-2055-2015
Product summary
- Firm
- Volk Optical Inc
- Event
- Event 71048
- Status
- Terminated
- Classification
- Class III
- Quantity
- 78 units
- Official record key
device-enforcement:Z-2055-2015
Official wording
Reason: Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.
Code information: Model: L90C, Lot: BE03356,
Distribution pattern: Distribution to VA only
Derived failure modes
-
Labeling or packaging
Mislabeling