BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALILEI G6 LENS PROFESSIONAL

    MDR report key: 10127159 · Received June 8, 2020

    Report

    Report Number
    9614468-2020-00001
    Event Type
    Injury
    Date Received
    June 8, 2020
    Date of Event
    February 27, 2020
    Report Date
    June 3, 2020
    Manufacturer
    SIS LTD., SURGICAL INSTRUMENT SYSTEMS
    Product Code
    MXK
    PMA / PMN Number
    K182659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    HYPERCORRECTION AFTER CATARACT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592237 GALILEI G6 LENS PROFESSIONAL GALILEI G6 LENS PROFESSIONAL MXK SIS LTD., SURGICAL INSTRUMENT SYSTEMS GALILEI G6 LENS PROFESSIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention