BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE USE PLUS MICROKERATOME

    MDR report key: 10864032 · Received November 18, 2020

    Report

    Report Number
    9615659-2020-00006
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    January 11, 2018
    Report Date
    November 10, 2020
    Manufacturer
    MORIA SA
    Product Code
    HMY
    PMA / PMN Number
    K040297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS THE RESULT OF A HISTORIC REVIEW BASED ON COMPANY INTERNAL CORRECTIVE & PREVENTIVE ACTION NC2ATY & NC4ATY.

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER REPORTED THEY HAD 'INCOMPLETE/PARTIAL FLAP' DURING LASIK SURGERY, AND ONE USE PLUS RING REF. 19354/110 LOT 1172714 DISASSEMBLED; WAS RIGHT /FIRST EYE; BELIEVES "TUBING POPPED OUT" AT START OF PASS, BLOCKED THE DISPOSABLE HEAD FROM MAKING FULL PASS. PATIENT IS OK, THEY WILL PERFORM PRK AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328198 ONE USE PLUS MICROKERATOME ONE USE PLUS MICROKERATOME HMY MORIA SA 19354/110 1172714

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other