BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP INLAY

    MDR report key: 9621955 · Received January 22, 2020

    Report

    Report Number
    MW5092424
    Event Type
    Injury
    Date Received
    January 22, 2020
    Date of Event
    November 10, 2017
    Report Date
    January 20, 2020
    Manufacturer
    REVISION OPTICS/RVO 2.0 INC.
    Product Code
    LQE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE RAINDROP INLAY PUT IN MY EYE. NOT ONLY DID IT NOT WORK AFTER MORE THAN A YEAR OF WAITING FOR MY EYES TO ADJUST¿ TO IT, IT GOT RECALLED. SINCE IT WAS REMOVED, MY VISION IS IMPAIRED IN THE AFFECTED EYE. EVEN WITH GLASSES, I HAVE BLURRY DISTANCE VISION. AND I HAVE A VERY DRY EYE THAT IS PAINFUL AT TIMES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82591 RAINDROP INLAY IMPLANT, CORNEAL, REFRATIVE LQE REVISION OPTICS/RVO 2.0 INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention