Vision One Laser System recall
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Why was Vision One Laser System recalled?
Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model: GA-0025020
- Product
- Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
- Recalling firm
- Lumenis, Inc.
- Quantity
- 3 units
- Distribution
- Distributed in the states of NJ, PA, and IL.
- Recall date
- September 18, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)