BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE USE PLUS MICROKERATOME

    MDR report key: 12092122 · Received June 30, 2021

    Report

    Report Number
    9615659-2021-00006
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 30, 2021
    Product Code
    HMY
    PMA / PMN Number
    K040297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICAL DATA COLLECTED FROM THE HEALTHCARE PROVIDER WAS INCOMPLETE (DID NOT CONTAIN THE 'WHITE-TO-WHITE').

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER REPORTED PATIENT HAD LASIK ON (B)(6) 2021, LOST SUCTION ON AN EYE DURING THE PASS RESULTING IN PARTIAL FLAP. MORIA REQUESTED THE ONE USE PLUS DISPOSABLE HEAD AND RING BE RETURNED, ALONG WITH EQUIPMENT, FOR EVALUATION; AND ASKED FOR THE LOT NUMBER OF THE DISPOSABLE INVOLVED. HEALTHCARE PROVIDER LATER REPORTED FLAP IS HEALING AND PLANNING PRK AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992529 ONE USE PLUS MICROKERATOME ONE USE PLUS MICROKERATOME HMY 1933X/XXX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other EVOLUTION 3E CONSOLE| ONE USE PLUS MOTOR