Device product
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits
Z-1806-2015
Product summary
- Event
- Event 71293
- Status
- Terminated
- Classification
- Class II
- Quantity
- 268 kits
- Official record key
device-enforcement:Z-1806-2015
Official wording
Reason: Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
Code information: Lot Numbers: 3068113 3078510 3086351 3089841 3096796
Distribution pattern: Nationwide Distribution including KY, GA, MI, and NJ.
Derived failure modes
-
Unknown
Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product