BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE MINIATURE TELESCOPE

    MDR report key: 4349927 · Received November 19, 2014

    Report

    Report Number
    3005251015-2014-00002
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    November 23, 2014
    Report Date
    November 19, 2014
    Manufacturer
    VISIONCARE OPHTHALMIC TECHNOLOGIES, INC.
    Product Code
    NCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, A PATIENT UNDERWENT TELESCOPE IMPLANTATION FOR END-STAGE MACULAR DEGENERATION. ON THE DAY ONE POSTOPERATIVE EXAM, THE PHYSICIAN REPORTED THAT THE PATIENT NOTES HAZE. THE CORNEA AND REST OF THE EYE IS CLEAR. THE PHYSICIAN REPORTED THAT THE IMPLANT LOOKS LIKE IT HAS "CONDENSATION" BEHIND THE FRONT SURFACE, SOMETHING HE ALSO NOTICED EARLY ON DURING THE SURGERY. AT THE DAY SEVEN POSTOPERATIVE VISIT, THE PROBLEM REMAINED. REFERENCE MFR # 3005347768-2014-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750735 IMPLANTABLE MINIATURE TELESCOPE TELESCOPE IMPLANTABLE MINIATURE NCJ VISIONCARE OPHTHALMIC TECHNOLOGIES, INC. WA 2.7 X 10506

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention