Device product
Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities
Z-1177-2016
Product summary
- Firm
- Volk Optical Inc
- Event
- Event 73213
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9 lens
- Official record key
device-enforcement:Z-1177-2016
Official wording
Reason: The firm discovered that the incorrect lot number was engraved on the product.
Code information: Model #: VG4SNF, Lot: BE05200
Distribution pattern: Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.
Derived failure modes
-
Unknown
The firm discovered that the incorrect lot number was engraved on the product.