BEUDAMED
    FDA Adverse Event Other Summary report: N

    MALYUGIN RING SYSTEM

    MDR report key: 3350061 · Received September 10, 2013

    Report

    Report Number
    3019924-2013-00032
    Event Type
    Other
    Date Received
    September 10, 2013
    Date of Event
    August 13, 2013
    Report Date
    September 4, 2013
    Manufacturer
    MICROSURGICAL TECHNOLOGY
    Product Code
    HOC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVICE TO THE FACILITY WAS TO REMOVE THE RING FROM THE EYE. ONE DAY POST-OP THE PT EXAMINATION WAS UNREMARKABLE AND THE SURGEON WAS NOT SURE OF THE LOCATION OF THE RING AND THE PT WAS REFERRED TO A RETINAL DOCTOR. THE SURGEON INDICATED THAT DUE TO THE PT'S MEDICAL HISTORY AND ONGOING MEDICAL OUTLOOK THAT THE RISK OF REMOVING THE RING WAS NOT SOMETHING THAT HE WISHED TO PURSUE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT WHEN THE SURGEON WAS INSERTING AND POSITIONING THE IOL THE TRAILING HAPTIC CAUGHT THE RING AND PULLED IT POSTERIORLY INTO THE SULCUS. THE SURGEON CHOSE TO LEAVE THE RING IN PLACE AND DID NOT REMOVE IT FROM THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452177 MALYUGIN RING SYSTEM IRIS CLIP HOC MICROSURGICAL TECHNOLOGY MAL-0001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other