BEUDAMED
    FDA Adverse Event Summary report: N

    IMPLANTABLE MINIATURE TELESCOPE

    MDR report key: 5610909 · Received April 27, 2016

    Report

    Report Number
    3005347768-2016-00001
    Date Received
    April 27, 2016
    Date of Event
    March 17, 2016
    Report Date
    April 19, 2016
    Manufacturer
    VISIONCARE OPHTHALMIC TECHNOLOGIES LTD
    Product Code
    NCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE INITIAL ATTEMPT TO INSERT THE IMT THE SURGEON ENCOUNTERED SOME DIFFICULTY GETTING THE LEADING HAPTIC INTO THE BAG. HE ABORTED THE ATTEMPT AND PULLED THE IMT BACK OUT. SHORTLY THEREAFTER HE TRIED AGAIN TO INSERT THE IMT AND IT BECAME APPARENT THAT THE HAPTIC WAS BROKEN. THE HAPTIC WAS FULLY SEPARATED AND PARTIALLY EXTENDED OUT OF THE WOUND. THE IMT TOGETHER WITH THE HAPTIC WAS REMOVED. THE SECOND (BACKUP) IMT WAS PREPARED AND SUCCESSFULLY PLACED IN THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268766 IMPLANTABLE MINIATURE TELESCOPE IMPLANTABLE MINIATURE TELESCOPE NCJ VISIONCARE OPHTHALMIC TECHNOLOGIES LTD WA 2.7X 10642

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention