BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP IMPLANT

    MDR report key: 10677263 · Received October 13, 2020

    Report

    Report Number
    MW5097214
    Event Type
    Injury
    Date Received
    October 13, 2020
    Report Date
    October 9, 2020
    Manufacturer
    REVISION / RVO 2.0, INC.
    Product Code
    LQE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LOSS OF VISION; NOTICE VISION BECOMING BLURRY, HAZY. WENT TO SEE (B)(6) EYE CENTER WHERE I HAD THE RAIN DROP SURGERY PERFORMED. I HAVE DEVELOPED CORNEA SCAR TISSUE BELOW AND ABOVE DUE TO THIS DEVICE, THE RAINDROP SURGERY I HAD IN 2017. FOUND OUT IT WAS TAKEN OFF MARKET 10/22/2018 DUE TO THE COMPLICATION IT HAS CAUSED PATIENTS; 4 OUT OF 5 SURGERIES HAVE BEEN PERFORMED TO THIS ISSUE. MY VISION HAS WORSENED AND I WAS NEVER CONTACTED ABOUT THIS RECALL. I AM SEEKING MY FULL MONEY BACK, (B)(6) AND AM HOPEFUL AFTER MY RECENT REMOVAL OF THIS DEVICE, I WON'T CONTINUE TO GET MORE SCAR TISSUE. I HAD SURGERY FOR REMOVAL ON (B)(6) 2020. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134316 RAINDROP IMPLANT IMPLANT, CORNEAL, REFRACTIVE LQE REVISION / RVO 2.0, INC. I DON'T KNOW I DON'T KNOW

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other