Reported Sep 18, 2013 · Terminated
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular…
Lumenis, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lumenis, Inc. · 3959 W 1820 S · Salt Lake City, UT · 84104
Is this the product you have?
- Vision One Laser System Model GA-0025020
- Serial No10050, 10051, 10053. Intended for use in the treatment of ocular pathology
- Lot codes and dates
- ModelGA-0025020
- Amount recalled
- 3 units
Where it was sold
Why it was recalled
Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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