BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACLEAR

    MDR report key: 24924660 · Received April 20, 2026

    Report

    Report Number
    3021550489-2026-00004
    Event Type
    Injury
    Date Received
    April 20, 2026
    Manufacturer
    ACCLARO CORPORATION
    Product Code
    GEX
    UDI-DI
    00850039149429
    PMA / PMN Number
    K233803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REACHED OUT DIRECTLY TO ACCLARO TO REPORT THIS COMPLAINT ON (B)(6) 2026 IN REGARD TO A TREATMENT THAT OCCURED ON (B)(6) 2025. THE PATIENT REPORTED TRACKMARKS ON THE NECK AFTER A LASER CORING TREATMENT AND PERSISTENT ERYTHEMA. LASER CORING DELIVERS LASER ENERGY TO A SMALL REGION AT HIGH DEPTHS OF 0.5MM TO 4MM. ACCLARO CLINICAL REACHED OUT TO THE TREATING PHYSICIAN TO DISCUSS THE ISSUE. THE TREATING PHYSICIAN REPORTED USING LASER CORING MODE AT 2% COVERAGE AND 2MM DRILL DEPTH. 2MM DEPTH IS VERY AGGRESSIVE TREATMENT AND HAS BEEN KNOWN TO CAUSE TRACKMARKS (ALSO KNOWN AS STAMPING, PIXELATED STAMPING, OR GRIDMARKS) AND DELAYED HEALING IN SOME CASES WHEN USED ON AN INAPPROPRIATE PATIENT AND/OR ANATOMICAL REGION. THE TRACKMARKS PRESENT IN THE PHOTOGRAPHS PROVIDED FOR THIS CASE ARE ATYPICAL. IN MOST CASES THEY APPEAR AS PINPOINT INDENTATIONS IN A GRID PATTERN. IN THIS CASE THEY APPEAR AS RAISED HYPOPIGMENTED DOTS. THE TYPICAL TRACKMARKS ARE KNOWN TO HEAL WITH TIME, THOUGH IT MAY BE A MATTER OF MONTHS. IN ONE OTHER REPORTED CASE WE HAVE SEEN TRACKMARKS PRESENT IN THIS WAY, INTERNAL RECORD NUMBER CMP-000065. IN THAT CASE THE TREATMENT WAS PERFORMED IN A SIMILAR REGION (NECK) AND AT DRILL DEPTHS OF 1MM. THE PATIENT CANCELLED ANY FOLLOW UP APPOINTMENTS. ACCLARO DETERMINED THIS WAS NOT REPORTABLE AS THE PHYSICIAN STATED THEY EXPECTED THE PATIENT TO HEAL AND NO INTERVENTIONS WERE TAKEN. IN THIS CASE, THE PATIENT IS CONTINUING TO WORK WITH THE TREATING PHYSICIAN AND THEY HAVE OFFERED TO PROVIDE HER WITH TOPICAL TREATMENTS AND OTHER INTERVENTIONS TO RESOLVE THE VISIBLE TRACKMARKS. THE ROOT CAUSE FOR THIS COMPLAINT IS DETERMINED TO BE TOO AGGRESSIVE PARAMETER SELECTION FOR THE PATIENT AND ANATOMICAL REGION BEING TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216696 ULTRACLEAR FRACTIONAL MID-IR LASER GEX ACCLARO CORPORATION AS-WB-00055 00850039149429

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention