BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP UNDERLAY LENS

    MDR report key: 9218459 · Received October 21, 2019

    Report

    Report Number
    MW5090519
    Event Type
    Injury
    Date Received
    October 21, 2019
    Date of Event
    October 17, 2019
    Report Date
    October 17, 2019
    Manufacturer
    REVISION / RVO 2.0, INC.
    Product Code
    LQE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RAINDROP LENS WAS SURGICALLY INSERTED IN (B)(6) 2017. I NOW HAVE BLURRY, HAZY VISION AND POOR NIGHT VISION. PRODUCT NEEDS TO BE SURGICALLY REMOVED. VISION AFTER THE PROCEDURE MAY BE ALTERED NEGATIVELY DUE TO RAINDROP LENS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006892 RAINDROP UNDERLAY LENS IMPLANT, CORNEAL, REFRACTIVE LQE REVISION / RVO 2.0, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other