BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAIN DROP CORNEAL INLAY

    MDR report key: 8482809 · Received April 3, 2019

    Report

    Report Number
    MW5085570
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    March 21, 2019
    Report Date
    April 1, 2019
    Manufacturer
    REVISION OPTICS/ RVO 2.0, INC
    Product Code
    LQE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD RAIN DROP CORNEAL INLAY IMPLANTED IN LEFT EYE APPROXIMATELY 2015-16. DEVELOPED VISION PROBLEMS AND WHEN I WENT IN FOR A YEARLY EYE CHECK (032119) WAS INFORMED OF A RECALL OF THE LENS AND SENT IMMEDIATELY TO HAVE IT REMOVED. THE LENS WAS REMOVED ON (B)(6) 2019 AFTER I MADE AN APPOINTMENT. DID NOT RECEIVE INFORMATION OF THE RECALL OR ANY POSSIBLE CORNEAL HAZE, INFLAMMATION WHICH COULD HAVE LEAD TO INFECTION, ISSUES I HAD BEEN EXPERIENCING OVER THE PAST YEAR. I AM EXPERIENCING POST OP DRY EYE ALONG WITH IRRITATION SINCE THE REMOVAL AND BEING TREATED WITH STEROIDS AND ANTIBIOTICS. LEFT EYE BLURRY. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270071 RAIN DROP CORNEAL INLAY IMPLANT, CORNEAL, REFRACTIVE LQE REVISION OPTICS/ RVO 2.0, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R