MicroSlad™ 715 MicromanipulatorRecalls & reported problems
Lumenis Ltd. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109141817), received between Aug 1, 2025 and Feb 5, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (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
- Failure to Align2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2026Failure to Align
IT WAS REPORTED THAT THAT AIMING BEAM WAS NOT MATCHED WITH WORKING LASER BEAM. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24274640 ↗MalfunctionAug 1, 2025Failure to Align; Failure to Align
IT WAS REPORTED THAT THE CUSTOMER CALLED THE TECHNICAL ASSESSMENT CENTER (TAC) TO REPORT THAT THE CO2 LASER WAS OUT OF ALIGNMENT. THE CUSTOMER WAS UNSURE WHETHER THE CO2 MISALIGNMENT WAS DUE TO THE MICROMANIPULATOR, OR THE LASER CONSOLE. IT WAS INDICATED THAT THE CONSOLE WAS NOT A BOSTON SCIENTIFIC MANUFACTURED CONSOLE. THE TAC RECOMMENDED TO UTILIZE THE CONSOLE BUT WITHOUT THE MICROMANIPULATOR. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22689042 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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