BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMUS MEDICAL LASER - HORIZON

    MDR report key: 22396327 · Received July 3, 2025

    Report

    Report Number
    3006120071-2025-00002
    Event Type
    Injury
    Date Received
    July 3, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 2, 2025
    Manufacturer
    SUMMUS MEDICAL LASER LLC
    Product Code
    ILY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4): ON THE MORNING OF JUNE 10, 2025, A TECHNICIAN WAS CHANGING THE LENS ON THE HORIZON LASER SYSTEM. ACCORDING TO THE DOCTOR, DURING THIS PROCESS THE LASER INADVERTENTLY ACTIVATED, AND THE BEAM STRUCK THE TECHNICIAN IN THE EYE. THE TECHNICIAN REPORTED EXPERIENCING A HEADACHE AND BLURRED VISION. THESE SYMPTOMS RESOLVED BY THE AFTERNOON OF THE SAME DAY, AND THERE HAVE BEEN NO FURTHER REPORTS OR COMMUNICATIONS REGARDING ONGOING SYMPTOMS. DURING DISCUSSION WITH THE DOCTOR, IT WAS DETERMINED THAT THE TECHNICIAN HAD LEFT THE DEVICE IN AN ACTIVE STATE WHILE CHANGING THE LENS. UPON REMOVAL OF THE LENS, THE TECHNICIAN INADVERTENTLY PRESSED THE ACTIVATION BUTTON (FINGER SWITCH) ON THE HANDPIECE, WHICH RESULTED IN THE LASER FIRING. THE TECHNICIAN WAS NOT WEARING PROTECTIVE SAFETY GOGGLES AT THE TIME, AS REQUIRED BY THE USER MANUAL. THE INVESTIGATION INDICATES THE DEVICE FUNCTIONED AS DESIGNED. THE INCIDENT RESULTED FROM USER ERROR, INCLUDING: FAILURE TO FOLLOW SAFETY INSTRUCTIONS (E.G., WEARING PROTECTIVE GOGGLES), ATTEMPTING TO CHANGE THE LENS WHILE THE DEVICE WAS IN AN ACTIVE OR READY STATE AND ACCIDENTAL PRESSING OF THE FINGER SWITCH.

    Description of Event or Problem · 0

    THE TECHNICIAN WAS CHANGING THE LENS ON THE LASER SYSTEM. DURING THIS PROCESS THE LASER INADVERTENTLY ACTIVATED, AND THE LASER BEAM STRUCK THE TECHNICIAN IN THE EYE. THE TECHNICIAN WAS NOT WEARING THE SAFETY GLASSES AS REQUIRED PER THE USER MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940081 SUMMUS MEDICAL LASER - HORIZON P4H ILY SUMMUS MEDICAL LASER LLC P4H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown