BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 8110851 · Received November 27, 2018

    Report

    Report Number
    MW5081663
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    September 7, 2017
    Report Date
    November 26, 2018
    Manufacturer
    REVISION OPTICS, INC.
    Product Code
    LQE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE RAINDROP NEAR VISION INLAY PROCEDURE. IMMEDIATELY AFTER THE PROCEDURE AND EVER SINCE, I HAVE REPORTED TO MY EYE DR THAT THE INLAY DID NOT WORK, DID NOT HELP WITH MY NEAR VISION AND CAUSED BLURRINESS AND GLARE. I WAS TOLD IT TAKES A LONG TIME FOR THIS TO GO AWAY. IT HAS NEVER GONE AWAY AND MY VISION IS WORSE WITH THE INLAY THAN BEFORE I HAD THE PROCEDURE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946697 RAINDROP NEAR VISION INLAY IMPLANT, CORNEAL, REFRACTIVE LQE REVISION OPTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR