BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALYUGIN RING

    MDR report key: 4092936 · Received September 10, 2014

    Report

    Report Number
    MW5038169
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY
    Product Code
    HNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MALYUGIN RING WAS PLACED DURING CATARACT SURGERY. A MALYUGIN RING BREAKAGE OCCURRED UPON REMOVAL FROM THE EYE. DAMAGE TO LENTICULAR ZONULES AND CAPSULE OCCURRED. DISLOCATION OF IOL WAS NOTED POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559680 MALYUGIN RING HNQ MICROSURGICAL TECHNOLOGY MALYUGIN RING 061104

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other