BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP CORNEAL INLAY

    MDR report key: 8487179 · Received April 4, 2019

    Report

    Report Number
    MW5085602
    Event Type
    Injury
    Date Received
    April 4, 2019
    Date of Event
    March 22, 2019
    Report Date
    April 2, 2019
    Manufacturer
    REVISION OPTICS / RVO 2.0, INC.
    Product Code
    LQE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FIN (B)(6) 2017, I HAD A RAINDROP CORNEAL INLAY IMPLANTED IN MY RIGHT EYE. ONE YEAR LATER IN (B)(6) 2018, I DEVELOPED CORNEAL HAZE WHICH AFFECTED MY VISION. I HAD THE LENS REPLACED AND THE HAZE WAS TREATED. APPROX 1 YR LATER IN (B)(6) 2019, I DEVELOPED THE HAZE AGAIN AND THIS TIME CAUSED HEADACHES. BLURRED VISION, AND LOSS OF DEPTH PERCEPTION. ON (B)(6) , I HAD THE INLAY REMOVED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274738 RAINDROP CORNEAL INLAY IMPLANT, CORNEAL, REFRACTIVE - RAINDROP POOR VISION INLAY LQE REVISION OPTICS / RVO 2.0, INC.
    274739 RAINDROP CORNEAL INLAY IMPLANT, CORNEAL, REFRACTIVE - RAINDROP POOR VISION INLAY LQE REVISION OPTICS / RVO 2.0, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R 81MG ASPIRIN | APPLE CIDER VINEGAR| ATORVASTATIN| CARVIDIOL| CINNAMON CAPSULES| LEVOTHYROXINE| LISINOPRIL| METFORMIN | VITAMIN D3