BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MST MALYUGIN RING

    MDR report key: 2497824 · Received February 17, 2012

    Report

    Report Number
    2497824
    Event Type
    Injury
    Date Received
    February 17, 2012
    Date of Event
    December 21, 2011
    Report Date
    December 22, 2011
    Manufacturer
    MST
    Product Code
    HNQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING CATARACT SURGERY, LEFT EYE, THE PUPIL WAS NOTED TO BE SMALL DESPITE VIGOROUS ATTEMPTS TO DILATE. A MALYUGIN RING WAS INSERTED EASILY BUT WHEN THE INSERTER WAS REMOVED FROM THE EYE, THERE WAS A LARGE TEAR IN THE ANTERIOR CAPSULE EXTENDING UNDER THE IRIS. THIS MADE THE CAPSULE UNSTABLE AND RISK OF EXTENSION TO POSTERIOR CAPSULE. IT DID NOT EXTEND BUT THE SULCUS 10L SEEMED SOMEWHAT UNSTABLE - DECENTERING BUT SEEMED CENTERED AT THE END OF CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MST MALYUGIN RING MALYUGIN RING HNQ MST MAL-000-1 039

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR