BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILIGHT¿

    MDR report key: 25092159 · Received May 6, 2026

    Report

    Report Number
    3021349626-2026-00005
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 6, 2026
    Manufacturer
    LUMENIS BE LTD
    Product Code
    GEX
    UDI-DI
    07290109145280
    PMA / PMN Number
    K193500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, PATIENT PHOTO. THE CUSTOMER REPORTED THAT THEY TREATED THEIR STAFF MEMBER WITH OPTILIGHT FOR ACNE WHO SUFFERED BURNS. SHE NOW HAS HYPERPIGMENTATION. SHE IS EITHER A IV OR V IN SKIN TYPE. THEY ASKING IF LUMENIS ABLE TO ASSIST IN PROVIDING THE PATIENT WITH NECESSARY TREATMENTS TO CORRECT THE HYPERPIGMENTATION. CUSTOMER FEELS THAT THIS HAPPENED IN PART BECAUSE OF THE INFORMATION THEY RECEIVED FROM YOUR TEAM ABOUT CANDIDATES FOR TREATMENT." SERVICE ENGINEER VISITED AND TESTED THEIR DEVICE. HE ADVISED AS FOLLOWS: "CONFIRMED CUSTOMER COMPLAINT OF 1082 ERROR. FOUND ALL IPL FILTERS FRICTION TABS LOOSE CAUSING 1082 WHEN USING OPTILIGHT PEN. ADJUSTED FRICTION TABS. FOUND OPTILIGHT PEN POWER OUTPUTS AT HIGH END OF ACCEPTABLE RANGE WHEN USING A NEW TIP. CALIBRATED PEN FROM POWER FACTOR 1.65 TO 1.55. VERIFIED ALL POWER OUTPUTS NOW IN MIDDLE OF ACCEPTABLE RANGE. UNIT IS READY TO USE." AN ERROR 1082 IS A SAFETY ERROR AND RAISING TO PREVENT DELIVERING OF EXCESSIVE ENERGY DURING MALFUNCTION. IT'S IMPOSSIBLE TO OPERATE THE DEVICE HAVING THIS ERROR. IN ADDITION, IPL FILTER'S MECHANICAL ISSUES ARE NOT RELATED TO THE ENERGY. THEREFORE, NO ONE OF THE REPORTED ISSUES, CANNOT BE A POTENTIAL CAUSE FOR SERIOUS INJURY. BASED ON THAT, WE CONCLUDE THAT DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. LUMENIS CLINICAL EXPERT ADVISED AS FOLLOWS: "9 - PERMANENT INJURY RESULTING IN PERMANENT IMPAIRMENT. "AN EMAIL WAS RECEIVED FROM THE PROVIDER DESCRIBING A TREATMENT PERFORMED ON A 22-YEAR-OLD FEMALE STAFF MEMBER WITH FITZPATRICK SKIN TYPE IV. THE OPTILIGHT AESTHETIC APPLICATION WAS USED TO ADDRESS ACNE IN THE CHEEK AREA. THE PROVIDER NOTED THAT THE INDIVIDUAL REPORTED A BURNING SENSATION IMMEDIATELY FOLLOWING THE TREATMENT, WHICH WAS FOLLOWED BY A BURN AND SUBSEQUENT POST-INFLAMMATORY HYPERPIGMENTATION THAT HAS PERSISTED SINCE THE TREATMENT IN MARCH. "THE PROVIDER INDICATED THAT THE ACNE FILTER WAS USED; HOWEVER, SPECIFIC TREATMENT PARAMETERS SUCH AS FLUENCE, PULSE DURATION, AND DELAY WERE NOT INCLUDED IN THE INCIDENT REPORT. ADDITIONALLY, NO PHOTOS OF THE TREATED AREA WERE PROVIDED. PROVIDER HAS BEEN NON-COMMUNICATIVE ON STAFF MEMBER STATUS AND TREATMENT EDUCATION. "ROOT CAUSE FAILURE: USER ERROR, PROVIDER NOTED ON THE REPORT THAT THE PATIENT HAD SUN EXPOSURE AND FAILED TO TEST PATCH ON RECOMMENDED PROTOCOLS. THE LITERATURE RECOMMENDS, PATCH TEST 24-48 HOURS PRIOR TO A FULL TREATMENT FOR A FITZPATRICK IV. POTENTIAL SCARRING AND RESIDUAL POST-INFLAMMATORY HYPERPIGMENTATION." SINCE THE INJURY IS SERIOUS THIS CASE IS REPORTABLE TO THE FDA. THE ROOT CAUSE IS USER ERROR BASED ON POOR HANDLING OF THE DEVICE OR ITS COMPONENTS. MOREOVER, LACK OF TEST SPOT IS NOT ACCORDING TO THE TREATMENT RECOMMENDATIONS. IN ADDITION, REPORTED MALFUNCTION IS NOT RELATED TO THE INJURY, BUT MECHANICAL ISSUE. THEREFORE, AN UPDATE TO THE REPORTABLE MALFUNCTION LIST IS NOT REQUIRED. BASED ON RISK FILE 1010197 RISK ANALYSIS AND REPORT FOR M22 AND STELLAR PLATFORM - USER NOT FOLLOWING TREATMENT INSTRUCTIONS (PAR. #22.1.1), INADEQUATE MAINTENANCE (#27.1), CAN LEAD TO TISSUE DAMAGE, BUT THESE RISKS HAVE BEEN EVALUATED AND REFERRED MITIGATIONS PUT THEM WITHIN ACCEPTABLE LIMITS.

    Description of Event or Problem · 0

    LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY OPTILIGHT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418999 OPTILIGHT¿ INTENSE PULSED LIGHT (IPL) SYSTEM, MULTI MODALITY SKIN SURFACE TREATMENT SYSTEM GEX LUMENIS BE LTD OPTILIGHT¿ 07290109145280

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Other