BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE USE PLUS MICROKERATOME

    MDR report key: 10864137 · Received November 18, 2020

    Report

    Report Number
    9615659-2020-00010
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    March 7, 2019
    Report Date
    November 11, 2020
    Manufacturer
    MORIA SA
    Product Code
    HMY
    PMA / PMN Number
    K040297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 'PARTIAL FLAP' DURING LASIK SURGERY, LOST SUCTION. PATIENT IS OK, COMING BACK FOR PRK AT A LATER DATE. ONE USE PLUS DISPOSABLE HEAD REF. 19337/130 WAS NOT SAVED; SENDING IN ONE USE PLUS MOTOR REF. 19345 FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329512 ONE USE PLUS MICROKERATOME ONE USE PLUS MICROKERATOME HMY MORIA SA 19345 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other