BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 10864119 · Received November 18, 2020

    Report

    Report Number
    9615659-2020-00009
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    March 28, 2019
    Report Date
    November 11, 2020
    Manufacturer
    MORIA SA
    Product Code
    HMY
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MORIA M2 BLADES WERE NOT USED. 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 PATIENT HAD PARTIAL FLAP DURING LASIK SURGERY, LEFT EYE ONLY, DUE TO SUCTION LOSS. DEEPER AND BIGGER FLAP WAS THEN CREATED AND PROCEDURE WAS COMPLETED. SURGEON REPORTED THE PATIENT WILL HAVE A NORMAL OUTCOME - "IS NOW 20/20". MORIA EVOLUTION 3E CONSOLE AND M2 MOTOR WERE USED; BUT MORIA M2 BLADES WERE NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329237 UNKNOWN UNKNOWN HMY MORIA SA UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other