BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 8964884 · Received September 4, 2019

    Report

    Report Number
    MW5089551
    Event Type
    Injury
    Date Received
    September 4, 2019
    Report Date
    August 31, 2019
    Manufacturer
    REVISION OPTICS, INC. /RVO 2.0, INC.
    Product Code
    LQE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RAINDROP NEAR VISION INLAY WAS IMPLANTED AND CAUSED IRREPARABLE DAMAGE TO CORNEA AND VISION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757297 RAINDROP NEAR VISION INLAY IMPLANT, CORNEAL, REFRACTIVE LQE REVISION OPTICS, INC. /RVO 2.0, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other