BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP INLAY

    MDR report key: 6979198 · Received October 26, 2017

    Report

    Report Number
    MW5072961
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    May 19, 2017
    Report Date
    October 24, 2017
    Manufacturer
    REVISION OPTICS INC.
    Product Code
    LQE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER HAVING THE RAINDROP INLAY SURGERY ON (B)(6) 2017, I HAD SEVERE BLURRY VISION, EXTREME DRY EYE, AND AN INCREASE IN VISIBLE FLOATERS. THE DRY EYE CONDITION IMPROVED BUT THE BLURRY VISION AND FLOATER DISTURBANCE CONTINUED. AFTER NEARLY 5 MONTHS WITH THE RAINDROP INLAY IN PLACE I CONTINUED TO HAVE THE NEED TO WEAR GLASSES SO I COULD AT LEAST SEE WITH MY RIGHT EYE TO MAINTAIN MY WORK. SO, WITH LITTLE TO NO VISUAL IMPROVEMENT AFTER 5 MONTHS, AND MY DAILY LIFE CONTINUALLY IMPACTED WITH THE NEGATIVE VISUAL OUTCOMES, MY RAINDROP INLAY WAS REMOVED. I AM STILL LEFT WITH A NUMBER OF VISIBLE FLOATERS THAT WEREN'T PRESENT BEFORE THE SURGERY, BUT AT LEAST THEY ARE LESS NOTICEABLE AFTER HAVING THE INLAY REMOVED. I HAVE ALWAYS BEEN AN EXTREMELY HEALTHY INDIVIDUAL AND NO VISUAL PROBLEMS OTHER THAN THE DEVELOPMENT OF NEED FOR READING GLASSES IN MY (B)(6). I PERSONALLY FEEL THAT THIS RAINDROP INLAY SURGERY NEGATIVELY IMPACTED MY VISION FOR WHATEVER REASON AND I HOPE MORE CAN BE LEARNED ABOUT IT. I NEVER HAD CLARITY WITH THE RAINDROP INLAY IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760757 RAINDROP INLAY IMPLANT, CORNEAL REFRACTIVE LQE REVISION OPTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR