BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2 MICROKERATOME

    MDR report key: 10864049 · Received November 18, 2020

    Report

    Report Number
    9615659-2020-00002
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    January 12, 2016
    Report Date
    November 10, 2020
    Manufacturer
    MORIA SA
    Product Code
    HMY
    PMA / PMN Number
    K002191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 (B)(4).

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER REPORTED THEY HAD CENTRAL ISLAND (BUTTON HOLE). PATIENT IS OK, SURGEON LAID DOWN FLAP AND WILL DO PRK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328455 M2 MICROKERATOME M2 MICROKERATOME HMY MORIA SA 19326 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other