Lumenis Vision One Laser System Recalled for Unintended Laser Exposure
Lumenis is recalling three Vision One Laser Systems due to a potential for unintended laser exposure to the user.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (laser exposure) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Lumenis, Inc. has initiated a recall of three units of the Vision One Laser System, Model GA-0025020. The specific serial numbers affected are 10050, 10051, and 10053. These devices are intended for use in the treatment of ocular pathology.
The recall was initiated due to a potential for unintended laser exposure to the user. The agency classifies this recall as Class II.
The affected units were distributed in the states of New Jersey, Pennsylvania, and Illinois. Users of these devices should contact Lumenis, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
- Manufacturer
- Lumenis, Inc.
- Category
- Medical Device — Laser System
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model: GA-0025020
Distribution
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