BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP CORNEAL INLAY

    MDR report key: 19392519 · Received May 23, 2024

    Report

    Report Number
    MW5155351
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    July 30, 2013
    Manufacturer
    RVO 2.0, INC.
    Product Code
    LQE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HI, MY NAME IS (B)(6), AND SOMETIME IN 2013, I WAS PART OF A FREE TRIAL FOR A RAINDROP CORNEAL INLAY IN MY RIGHT EYE. IT WAS TO HAVE BETTER VISION. LAST YEAR, I STARTED HAVING TROUBLE WITH MY EYES, SO I WENT TO MY REGULAR EYE DOCTOR, WHO PROVIDED ME WITH A CONTACT-LIKE BAND-AID THAT I NEED TO HAVE 24/7 TO RELIEVE PAIN. I CONTACTED THE OFFICE THAT INITIALLY PUT THE RAINDROP INLAY IN MY EYE, AND THEY SAW ME AND TOLD ME THAT SOMEONE SHOULD HAVE CONTACTED ME A LONG TIME AGO TO REMOVE IT. HE THEN CALLED MY REGULAR EYE DOCTOR ON THE PHONE. I DON'T KNOW WHAT WAS SAID, BUT MY REGULAR EYE DOCTOR'S OFFICE CALLED ME TO SEE THE PRIMARY DOCTOR THE NEXT DAY. AT THAT TIME THAT IS WHEN HE LOOKED AT MY EYE AND SAID MY CORNEAL WAS DAMAGED AND PROVIDED ME WITH THIS ARTICLE TITLE BELOW. (TICKING TIMEBOMBS FOLLOWING THE RECALL OF THE RAINDROP CORNEAL INLAY, EFFORTS MUST BE MADE TO NOTIFY ALL REMAINING AFFECTED PATIENTS). PLEASE LET ME KNOW IF THIS IS SOMETHING YOU CAN HELP ME WITH. THANK YOU, (B)(6). RECALL INLAY WAS NEVER TOLD AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2321085 RAINDROP CORNEAL INLAY IMPLANT, CORNEAL, REFRACTIVE LQE RVO 2.0, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other XANAX.