BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACLEAR

    MDR report key: 24533796 · Received March 6, 2026

    Report

    Report Number
    3021550-2026-00003
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    October 23, 2025
    Report Date
    March 3, 2026
    Manufacturer
    ACCLARO CORPORATION
    Product Code
    GEX
    UDI-DI
    00850039149429
    PMA / PMN Number
    K210847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS TREATED WITH LASER CORING AT 5% COVERAGE AND 1.5MM DRILL DEPTH IN THE SUBMENTAL REGION, AND 5% COVERAGE AND 1MM DRILL DEPTH IN THE LOWER FACE. A SECOND TREATMENT PASS OVER BOTH TREATMENT AREAS OF CLEAR MODE AT 35% COVERAGE AND 30UM RING DEPTH. PHOTOGRAPHS SHOW LAXITY IN THE SUBMENTAL REGION 4 WEEKS POST TREATMENT. FURTHER PHOTOGRAPHS SHOW THAT THE LAXITY HAS NOT REDUCED 4 MONTHS POST TREATMENT. ACCLARO CLINICAL REACHED OUT TO AN ACCLARO KEY OPINION LEADER (KOL) FOR HIS CLINICAL OPINION OF THE CASE. THE KOL CONTACTED IS A DERMATOLOGIST WITH SIGNIFCANT EXPERIENCE USING LASER DEVICES AND SPECIFICALLY USING THE ULTRACLEAR DEVICE. THE KOL STATED IN EMAIL THAT HE SUSPECTED WITH TREATMENT DEPTHS THIS DEEP ON THE SUBMENTAL REGION OF A THIN PATIENT IT IS LIKELY THAT ENERGY WAS DELIVERED TO THE HYPODERMIS RESULTING IN FAT INJURY AND VOLUME LOSS. HE SUSPECTED THAT THE LAXITY WOULD IMPROVE OVER TIME BUT WAS UNLIKELY TO RESOLVE COMPLETELY ON ITS OWN. HE SUGGESTED A COMBINATION OF TREATMENTS TO REMEDY THE LAXITY INCLUDING FURTHER ULTRACLEAR TREATMENT AT A SUPERFICIAL LEVEL FOCUSING ON SKIN TIGHTENING IN COMBINATION WITH BIOSTIMULATORY VOLUME RESTORATION. ACCLARO CLINICAL MET WITH THE STAFF OF THE TREATING CLINIC TO DISCUSS THE PATIENT'S SPECIFIC CASE AND TO DISCUSS PARAMETER SELECTION. AFTER DISCUSSION THE PATIENT OPTED FOR FURTHER SUPERFICIAL ULTRACLEAR TREATMENT WITH A FOCUS ON SKIN TIGHTENING BUT OPTED AGAINST OTHER SUGGESTIONS. ACCLARO CLINICAL DISCUSSED THE NEED TO USE LESS AGGRESSIVE SETTINGS AND TO CATER DRILL DEPTH TO THE SPECIFIC REGIONS AND SKIN THICKNESS OF INDIVIDUAL PATIENTS. FURTHER A CLINICAL TRAINING FOR ALL PROVIDERS AT THE CLINIC IS SCHEDULED INCLUDING AN EXERCISE IN PARAMETER SELECTION. THE ROOT CAUSE OF THIS ADVERSE EVENT IS DETERMINED TO BE TOO DEEP AND AGGRESSIVE CORING SETTINGS IN THE SUBMENTAL REGION OF A THIN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612220 ULTRACLEAR FRACTIONAL MID-IR LASER GEX ACCLARO CORPORATION AS-WB-00055 00850039149429

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Disability