BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE MINIATURE TELESCOPE

    MDR report key: 4038045 · Received June 5, 2014

    Report

    Report Number
    3005251015-2014-00001
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    April 9, 2012
    Report Date
    April 10, 2012
    Manufacturer
    VISIONCARE OPHTHALMIC TECHNOLOGIES, INC.
    Product Code
    NCJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 A PT UNDERWENT TELESCOPE IMPLANTATION FOR END-STAGE MACULAR DEGENERATION. AT THE DAY ONE POSTOPERATIVE EXAM, THERE WERE NO SIGNS OF INFECTION. AGAIN AT THE ONE-WEEK POSTOPERATIVE VISIT THERE WAS NO SIGN OF INFECTION. THE PT WAS DIAGNOSED WITH AN EYE INFECTION ON (B)(6) 2014. THE PT WAS SEEN BY THE SURGEON ON (B)(6) 2014, AND AN EVISCERATION OF THE EYE WAS PERFORMED ON (B)(6) 2014. A CULTURE WAS TAKEN TO IDENTIFY THE CAUSE OF THE INFECTION AND IT HAS BEEN IDENTIFIED AS (B)(6). THE SOURCE OF THIS INFECTION HAS NOT BEEN IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329768 IMPLANTABLE MINIATURE TELESCOPE NCJ VISIONCARE OPHTHALMIC TECHNOLOGIES, INC. WA 2.7X 10637

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention