BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP INLAY

    MDR report key: 8470635 · Received March 29, 2019

    Report

    Report Number
    MW5085424
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    January 5, 2018
    Report Date
    March 27, 2019
    Manufacturer
    RVO 2.0, INC.
    Product Code
    LQE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE RAIN DROP IMPLANTED IN MY LEFT EYE ON (B)(6) 2018. I HAD A HORRIBLE EXPERIENCE. A FEW HOURS AFTER SURGERY, I HAD SEVERE (CRYING) PAIN. I COULDN'T READ MY COMPUTER FOR WORK. THE STARBURST AND GLARES WERE TERRIBLE. I WAS AFRAID I WOULD GET INTO AN ACCIDENT WHILE DRIVING, DUE TO OBJECT BEING SO DISTORTED. I FOUND MYSELF GETTING OFF THE ROAD BECAUSE I COULDN'T BE SURE WHICH LANE CARS WERE IN. IT WAS TOO HAZARDOUS FOR ME TO DRIVE AT NIGHT. I COULD READ THE EYE CHART, BUT THE BLACK LETTERS WERE BLURRY, LIGHT GRAY IN COLOR AND DISTORTED. I WAS TOLD THAT MY VISION HAD GREATLY IMPROVED, IMPOSSIBLE. MY RAINDROP WAS REMOVED A YEAR LATER. I'M EXPERIENCING SHARP PAIN IN MY EYE, HEADACHES, TWITCHING OF THE EYE AND CONSTANT DRY EYE. I'M BACK TO USING EYE GLASSES. I'M CONCERNED THIS NIGHTMARE IS NOT OVER. RIDICULOUS. CLASS 1 RECALL OF ALL DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260445 RAINDROP INLAY IMPLANT, CORNEAL, REFRACTIVE LQE RVO 2.0, INC. RD1-1

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention