MAUDE Adverse Event Report: ALMA LASERS LTD. ALMA HARMONY CONSOLE WITH GREEN DIODE; POWERED LASER SURGICAL INSTRUMENT

Model Number	1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient sustained a burn at the treatment site following use of the alma harmony system.The facility further reported that the clearskin handpiece used with the alma harmony system during the treatment began leaking water after the burn occurred.Alma lasers inc.Conducted an initial investigation and determined that the reported burn appeared superficial and was expected to resolve.During follow-up communication with the user facility on february 5, 2026, the facility alleged that the patient subsequently developed a scar as a result of the burn.No updated photographs or additional clinical documentation were provided to support this allegation.This event is being reported in good faith.Alma lasers inc.Has made due diligence efforts to obtain the device for further evaluation; however, as of the date of this report, the device has not been returned by the user facility.

• Brand Name: ALMA HARMONY CONSOLE WITH GREEN DIODE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ALMA LASERS LTD.; 18 haharash street; north industrial park, caesarea 30798 95; IS 3079895
• MDR Report Key: 24301032
• Report Number: 3004450661-2026-00002
• Device Sequence Number: 9678869
• Product Code: GEX
• UDI-Device Identifier: 07290110123369
• UDI-Public: 07290110123369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2026
• Report Date (Section F): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1
• Device Catalogue Number: AAHG25102201BR0002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/10/2026
• Device Age: 13 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/09/2026