Device product
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits
Z-1804-2015
Product summary
- Event
- Event 71293
- Status
- Terminated
- Classification
- Class II
- Quantity
- 585 kits
- Official record key
device-enforcement:Z-1804-2015
Official wording
Reason: Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
Code information: Lot Numbers: 3039720 3046211 3047770 3049473 3070763 3082330 3089827 3093682 3095941 3106407 3117874
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