BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALYUGIN RING SYSTEM

    MDR report key: 14880779 · Received June 30, 2022

    Report

    Report Number
    3019924-2022-00003
    Event Type
    Injury
    Date Received
    June 30, 2022
    Report Date
    June 30, 2022
    Manufacturer
    MICROSURGICAL TECHNOLOGY INC.
    Product Code
    HOC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE SITE HAS BEEN UNRESPONSIVE SINCE THE INITIAL REPORT. THE RING WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    THE FACILITY REPORTED THAT UPON INSERTING THE IOL INTO THE CAPSULAR BAG THE MALYUGIN RING WAS SNARED AND ENCAPSULATED WITH THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205832 MALYUGIN RING SYSTEM IRIS RETRACTOR CLIP HOC MICROSURGICAL TECHNOLOGY INC. MAL-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other