AcuSpot AcuSpot 712 Z MicromanipulatorRecalls & reported problems
Lumenis Ltd. · Additional DM DIs: 07290109144306 07290109144313 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07290109141954), received between Jul 17, 2024 and Sep 3, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Align6
- Activation, Positioning or Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Failure to Align; Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50600014 ↗MalfunctionSep 3, 2025Failure to Align; Failure to Align
IT WAS REPORTED THAT THE MICROMANIPULATOR MIRROR IS NOT ALIGNING CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22953950 ↗MalfunctionFeb 25, 2025Failure to Align; Failure to Align
IT WAS REPORTED THAT THE CONSOLE WAS NOT SHOOTING STRAIGHT, AND IT IS MISALIGNED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21459905 ↗MalfunctionSep 5, 2024Failure to Align; Failure to Align
IT WAS REPORTED THAT THE MICROMANIPULATOR NEEDS ALIGNMENT. THE DEVICE IS WORKING, HOWEVER THE ALIGNMENT SEEMS TO BE OFF TO THE LEFT WHEN IT IS IN USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20142374 ↗MalfunctionAug 22, 2024Failure to Align; Failure to Align
IT WAS REPORTED THAT THE POINTER IS NOT ALIGNING WITH LASER ON MICROMANIPULATOR. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20024389 ↗MalfunctionJul 17, 2024Failure to Align; Failure to Align
IT WAS REPORTED THAT THE AIMING AND BURN BEAM WERE OUT OF ALIGNMENT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19767983 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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