OptiLight™Recalls & reported problems
Lumenis Ltd. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109145280), received between May 6, 2026 and May 6, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Incorrect Control/Treatment Settings2
Patient problems
- Burn(s)2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2026Use of Incorrect Control/Treatment Settings
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY OPTILIGHT DEVICE.
Patient problems: Burn(s)
MAUDE report 25092300 ↗InjuryMay 6, 2026Use of Incorrect Control/Treatment Settings
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY OPTILIGHT DEVICE.
Patient problems: Burn(s)
MAUDE report 25092159 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.