BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP INLAY

    MDR report key: 8090039 · Received November 19, 2018

    Report

    Report Number
    MW5081490
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    July 26, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DECREASED VISION AND CORNEAL EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923211 RAINDROP INLAY IMPLANT CORNEAL REFRACTIVE LQE REVISION OPTICS INC. 003054

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention