BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU

    MDR report key: 745214 · Received July 12, 2006

    Report

    Report Number
    MW1039691
    Event Type
    Injury
    Date Received
    July 12, 2006
    Date of Event
    March 4, 2006
    Report Date
    June 23, 2006
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED RENU MULTI PLUS AT THE END OF FEBRUARY AND DEVELOPED SYMPTOMS. I USED RENU PRODUCTS WHEN I TRAVEL AND INFREQUENTLY, IF NEEDED WHEN BIKING OR WHEN I AM OUT (CARRIED IN MY PURSE). I WOKE UP WITH EYE PAIN AND UNABLE TO SEE. I WENT TO THE ER AND IT WAS THE NEXT DAY THAT MY VISION WAS MUCH WORSE IN THE LEFT EYE ( I COULD SEE LIGHT). I HAVE BEEN TREATED AT EYE CLINIC SINCE MARCH. I CANNOT READ WITH MY LEFT EYE DUE TO THE SCAR LEFT BY THE FUNGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU * LPN BAUSCH & LOMB * GJ2006
    2 RENU * LPN BAUSCH & LOMB * GF40248

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R| S