BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2SU MICROKERATOME

    MDR report key: 10864010 · Received November 18, 2020

    Report

    Report Number
    9615659-2020-00007
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    March 20, 2018
    Report Date
    November 10, 2020
    Manufacturer
    MORIA SA
    Product Code
    HMY
    PMA / PMN Number
    K022560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 BUTTON HOLE DURING LASIK SURGERY; LEFT (2ND) EYE; SURGERY WAS ABORTED; PATIENT WILL HAVE PRK IN A FEW MONTHS. DISPOSABLE HEAD REF. 19334/90 WAS DISCARDED; SENDING M2 MOTORS REF. 19326 AND M2 RINGS REF. 19325/XX TO MORIA FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327937 M2SU MICROKERATOME M2SU MICROKERATOME HMY MORIA SA 19334/90 2161304

    Patients

    Seq Age Sex Outcome Treatment
    1 Other