BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR X

    MDR report key: 24017725 · Received January 9, 2026

    Report

    Report Number
    1720381-2026-00001
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    December 11, 2025
    Report Date
    January 9, 2026
    Manufacturer
    BIOS S.R.L.
    Product Code
    GEX
    PMA / PMN Number
    K161632
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BIOS RECEIVED THE INVESTIGATION REPORT FROM THE IMPORTERM(LUMENIS). "LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. ATTEMPTS BY EMAILS AND PHONE CALLS HAVE BEEN MADE TO OBTAIN; PATIENT TREATMENT SETTINGS, PATIENT INFORMATION AND PATIENT PHOTO. NO INCIDENT FORM OR PATIENT PHOTO HAS BEEN RECEIVED IN LUMENIS." AN EXAMINATION OF THE SUBJECT DEVICE WAS PERFORMED BY LUMENIS SERVICE ENGINEER AFTER VERIFYING ALL SYSTEM FUNCTIONS INCLUDING PERFORMING FULL SYSTEM ALIGNMENT AND CALIBRATION. UNABLE TO REPRODUCE ROOT CAUSE OFF ISSUE REPORTED BY CUSTOMER. OBSERVED SMALL SPOT ON FOCUS LENS. CHECKED ALL OPTICS. REPLACED FOCUS LENS, 45 DEGREE, REPLACED ND:YAG LAMP AND COOLING HOSE HAD CRIMP, ALL REPLACED PROACTIVELY. PERFORMED ALL STEPS ON SERVICE CHECKLIST. THE SYSTEM OPERATING WITHIN LUMENIS SPECIFICATION. THE DEVICE WAS INSTALLED ON MAY 05, 2025 AND STILL UNDER WARRANTY. DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. CLINICAL EVALUATION WASN'T PERFORMED, SINCE NO INCIDENT FORM OR PHOTOS WERE SENT TO LUMENIS. WHILE THE INFORMATION RECEIVED TO DATE DOES NOT CONFIRM THAT A SERIOUS INJURY NOR MALFUNCTION HAD OCCURRED, BECAUSE OF THE LACK OF INFORMATION BIOS IS REPORTING THE EVENT IN AN 'ABUNDANCE OF CAUTION'. SHOULD ADDITIONAL SIGNIFICANT INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY, AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    BIOS REVEIVED FROM LUMENIS, THE IMPORTER. AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPLENDOR X DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82039 SPLENDOR X FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG) GEX BIOS S.R.L. SPLENDOR X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other