BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAIN DROP NEAR VISION INLAY

    MDR report key: 9505961 · Received December 19, 2019

    Report

    Report Number
    MW5091821
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Manufacturer
    RVO 2.0, INC
    Product Code
    LQE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I DON'T KNOW THE EXACT DATE, MY EYES REALLY STARTED ITCHING IN EARLY SUMMER, I THOUGHT MAYBE ALLERGIES SO I WAITED IT OUT. MY EYES ARE EVEN WORSE NOW, ITCH ALL THE TIME, WATER AND TEAR AND ARE BLURRY. I CONTINUE TO GET EYE STY'S AND TENDER EYELIDS ALONG WITH SWELLING IN THE CORNER OF MY EYE. I HAVE AN APPT WITH MY EYE DR ON MONDAY, (B)(6) 2019. OPTICS MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286745 RAIN DROP NEAR VISION INLAY IMPLANT, CORNEAL, REFRACTIVE LQE RVO 2.0, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR