MosesRecalls & reported problems across all models
Lumenis Ltd. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 768
- Deaths reported
- 1
- Injuries reported
- 76
- Recalls
- 0
We found 4 models of Moses by Lumenis Ltd. in the FDA's device registry (GUDID). Together they are named in 768 adverse event reports in the FDA's MAUDE database, received between Jan 20, 2019 and Sep 30, 2026 — classified as 1 death, 76 injuries, 691 malfunctions.
The most frequently reported specific device problem is “Break” (558 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Moses problems
Device problems
- Break558
- Adverse Event Without Identified Device or Use Problem88
- Defective Device63
- Nonstandard Device48
- Power Problem33
- Material Integrity Problem31
- Overheating of Device17
- Separation Problem15
Patient problems
- No Clinical Signs, Symptoms or Conditions664
- Burn(s)62
- No Known Impact Or Consequence To Patient11
- Insufficient Information10
- Foreign Body In Patient4
- Superficial (First Degree) Burn4
- No Consequences Or Impact To Patient3
- Perforation3
Moses models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Moses™ AC-10030100Powered Laser Surgical Instrument532 reports
- Moses™ Moses™ 550 D\F\LPowered Laser Surgical Instrument1 death153 reports
- Moses™ Moses™ 365 D\F\LPowered Laser Surgical Instrument82 reports
- Moses™ Moses™ 200 D/F/L LPPowered Laser Surgical Instrument1 report
Recent Moses adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952630 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952624 ↗MalfunctionSep 30, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950016 ↗MalfunctionSep 30, 2026Nonstandard Device; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949573 ↗MalfunctionSep 29, 2026Optical Problem; Output Problem; Noise, Audible
During operation of moses laser staff noticed a "popping" and "cracking" sound. It was also noted the aiming beam was automatically turned off. The laser fiber was replaced, and the laser blast shield was changed. Laser fiber saved for materials management and blast shield given to plant ops. Patient was monitored. Supervisor notified.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927375 ↗MalfunctionSep 28, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926219 ↗MalfunctionSep 28, 2026Break
It was reported that during a lithotripsy procedure, the fiber broke during use. The procedure was completed with another fiber without patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915004 ↗MalfunctionSep 23, 2026Nonstandard Device; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873894 ↗MalfunctionSep 22, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862325 ↗MalfunctionSep 21, 2026Thermal Decomposition of Device; Nonstandard Device
It was reported that during a procedure, there was a noise and the fiber blew up. The procedure was completed without patient complications by replacing the fiber. Product analysis of the returned device identified a fracture at the fiber cap/tip.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848464 ↗MalfunctionSep 17, 2026Material Integrity Problem
It was reported that during the pre-use check, the fiber was found to be unusable. Another lot of the device was used to complete the procedure. There was no patient complication. After that, the fiber was returned for analysis and the microscope inspection found that the fiber connector had distorted light exiting the face, indicating an internal connector fracture.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806120 ↗MalfunctionSep 17, 2026Break
It was reported that during procedure, the fiber broke at the glass tip. The physical fractured of the fiber could not be confirmed but a cracked was heard. The procedure was completed as it was able to basket out the rest of the stones after the fiber broke. There were no patient complications. Customer mentions that this has been a recurrent issue with fibers of 200 micrometers. In the past the fibers were replaced for a different lot number to see if that could be contributing to the issue. The console settings were checked during visit, and they were set correctly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802104 ↗MalfunctionSep 11, 2026Break; Material Integrity Problem
It was reported that during procedure, the fiber snapped and sparked. The procedure was completed using another fiber. There were no patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735992 ↗MalfunctionSep 10, 2026Break
It was reported that during a procedure, the fiber broke it was notices that no aiming beam or power was hitting the stone and when pulling out the fiber it was noticed that the broken piece was still inside, the part was retrieved using a basket. The procedure was completed by replacing the fiber without patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713625 ↗MalfunctionSep 9, 2026Break; Thermal Decomposition of Device
It was reported that during an ureteroscopy procedure to treat kidney stone, the fiber was plugged in, and the surgeon was firing on the stone when the tip of the fiber broke off. The procedure was completed using another fiber of the same model. There was no patient complication.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699658 ↗
Other Lumenis Ltd. products
All Lumenis Ltd. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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