Device product
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Z-2191-2013
Product summary
- Firm
- Lumenis, Inc.
- Event
- Event 66133
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-2191-2013
Official wording
Reason: Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
Code information: Model: GA-0025020
Distribution pattern: Distributed in the states of NJ, PA, and IL.
Derived failure modes
-
Unknown
Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.