BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORESEE HOME

    MDR report key: 16818063 · Received April 25, 2023

    Report

    Report Number
    MW5117060
    Event Type
    Injury
    Date Received
    April 25, 2023
    Date of Event
    April 11, 2023
    Report Date
    April 21, 2023
    Manufacturer
    NOTAL VISION LTD.
    Product Code
    HPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    GOT A PHONE CALL FROM NOTAL VISION TO CALL MY RETINA SPECIALIST ASAP BECAUSE I HAD ABNORMAL RESULTS INDICATING A RETINAL PROBLEM AND THAT THESE RESULTS DATED BACK TO JANUARY AND HAD BEEN SENT TO MY SPECIALIST. I SAW MY SPECIALIST LATER THAT WEEK AND SHE SAW NO CHANGES IN MY RETINA. NOR COULD MY SPECIALIST FIND ANY EMAILS FROM NOTAL VISION(FORESEE HOME). I'M CONCERNED ABOUT THIS FALSE POSITIVE AND HOW MANY SUCH FALSE + ARE BEING GENERATED BY THIS DEVICE. I WAS QUITE ANXIOUS UNTIL MY SPECIALIST SAW ME BOTH MY TIME AND HER TIME WERE WASTED BY THIS FALSE +. I SAW MY RETINA DOC ON THAT FRIDAY AND HAD TO HAVE BOTH MY EYES DILATED, HAVE OCULAR TOMOGRAPHY AND THEN A SLIT-LAMP EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336702 FORESEE HOME PERIMETER, AUTOMATIC, AC-POWERED HPT NOTAL VISION LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male AGE-RELATED EYE DISEASE STUDIES| ASPIRIN| ATORVASTATIN| COLCHICINE| FINASTERIDE| TIMOPTIC DROPS| VIT D