Device product
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
Z-1803-2015
Product summary
- Event
- Event 71293
- Status
- Terminated
- Classification
- Class II
- Quantity
- 384 kits
- Official record key
device-enforcement:Z-1803-2015
Official wording
Reason: Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
Code information: Lot Numbers: 3038787 3046210 3061080 3078492 3093681 3095940 3108668
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