BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP INLAY

    MDR report key: 8090054 · Received November 19, 2018

    Report

    Report Number
    MW5081491
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    September 6, 2017
    Report Date
    November 16, 2018
    Manufacturer
    REVISION OPTICS INC.
    Product Code
    LQE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DECREASED VISION, CORNEAL HAZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923208 RAINDROP INLAY IMPLANT CORNEAL REFRACTIVE LQE REVISION OPTICS INC. 003109

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention