BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU WITH MOISTURE LOC

    MDR report key: 715839 · Received May 17, 2006

    Report

    Report Number
    MW1039208
    Event Type
    Injury
    Date Received
    May 17, 2006
    Date of Event
    July 4, 2004
    Report Date
    May 11, 2006
    Manufacturer
    BAUSCH & LOMB SOLUTIONS
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED RENU SOLUTIONS AND RENU MOISTURE LOC CONTACT LENS SALINE SOLUTIONS FROM 09/01/1991 THROUGH 094/06. ON 07/04/04; I AWOKE AND HAD EYE PIAN, 2 WHITE DOTS IN MY EYE AND DISCHARGE AND COULD NOT SEE OUT OF MY RIGHT EYE. I WENT TO HOSP AROUND SUMMER OF 2004 AND WAS DIAGNOSED WITH KERATITIS INFECTION AND WENT THROUGH MASSIVE ANTI FUNGAL THERAPY AND REQUIRE A CORNEAL TRANSPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU WITH MOISTURE LOC * LPN BAUSCH & LOMB SOLUTIONS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O| R| S