BEUDAMED
    FDA Adverse Event Summary report: N

    MALYUGIN RING SYSTEM

    MDR report key: 4904037 · Received July 9, 2015

    Report

    Report Number
    3019924-2015-00023
    Date Received
    July 9, 2015
    Date of Event
    June 9, 2015
    Report Date
    July 9, 2015
    Manufacturer
    MICROSURGICAL TECHNOLOGY INC
    Product Code
    HOC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT THERE WAS NO INFORMATION AVAILABLE AS TO THE CIRCUMSTANCES THAT LEAD TO THE RING BEING LEFT IN THE EYE. THE RETINAL SURGEON INITIALLY REPORTED THE SITUATION AND HAD NO RELEVANT INFORMATION REGARDING THE ACTUAL INCIDENT. THE RING WAS SUCESSFULLY REMOVED FROM THE PATIENT'S EYE AND THE PATIENT WAS DOING WELL ONE WEEK POST-OP.

    Description of Event or Problem · 1

    DURING CATARACT SURGERY THE MALYUGIN RING WAS LEFT IN THE EYE. A SECOND SURGERY WAS REQUIRED BY A RETINAL SURGEON TO REMOVE THE RING FROM THE EYE. THE RING WAS REMOVED WITHOUT IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445898 MALYUGIN RING SYSTEM CLIP, IRIS RETRACTOR HOC MICROSURGICAL TECHNOLOGY INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other