BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERISYSE MYOPIA

    MDR report key: 13052015 · Received December 21, 2021

    Report

    Report Number
    8040449-2021-00004
    Event Type
    Injury
    Date Received
    December 21, 2021
    Report Date
    December 15, 2021
    Manufacturer
    OPHTEC BV
    Product Code
    MTA
    PMA / PMN Number
    P030028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    PATIENT'S IOL WAS EXPLANTED, SINCE IT WAS CAUSING THE RIGHT EYE'S CELL CONE TO DIMINISH. IOL INFORMATION: VERISYSE MYOPIA IOL 6/8.5, DIOPTER -6.0, SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948190 VERISYSE MYOPIA VERISYSE MTA OPHTEC BV VRSM6

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention