Device product
EyeBOX Model OCL 02
Z-2398-2019
Product summary
- Firm
- OCULOGICA
- Event
- Event 82922
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-2398-2019
Official wording
Reason: A review of the user manual revealed that two precaution statements were missing.
Code information: Serial Numbers TT003, TT004, TT005
Distribution pattern: The products were distributed to the following US states: MD and NY
Derived failure modes
-
Unknown
A review of the user manual revealed that two precaution statements were missing.