BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYSEPT ULTRACARE FORMULA

    MDR report key: 1398178 · Received June 1, 2009

    Report

    Report Number
    MW5011274
    Event Type
    Injury
    Date Received
    June 1, 2009
    Date of Event
    May 27, 2009
    Report Date
    June 1, 2009
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN USING OXYSEPT ULTRACARE CONTACT FORMULA, AND I HAVE BEEN REPEATEDLY EXPERIENCING WHAT I THOUGHT WAS PINK EYE. I DISCONTINUED USE OF ANY MAKE-UP FOR THE PAST TWO MONTHS, BUT I WAS STILL HAVING RECURRENT ISSUES WITH MY EYES BECOMING RED AND IRRITATED WITH YELLOW DRAINAGE. I HAD GENTAMICIN ON HAND WHICH HAD BEEN PRESCRIBED FOR A PREVIOUS DIAGNOSIS OF CONJUNCTIVITIS, AND I WOULD USE THAT UNTIL THE INFECTION CLEARED, I WOULD OPEN A NEW SET OF CONTACTS, BUT THE INFECTION WOULD INEVITABLY RECUR. I HERD THE NEWS REPORT ABOUT THE COMPLETE MOISTUREPLUS, AND CHECKED TO SEE IF THAT WAS WHAT I WAS USING, AND I REALIZED THAT THE SOLUTION I HAD WAS ALSO MANUFACTURED BY ADVANCED MEDICAL OPTICS, INC AND I WAS CONCERNED THAT PERHAPS THIS SOLUTION IS ALSO TAINTED AND CAUSING MY PROBLEMS. ROUTE: OPHTHALMIC. DATES OF USE: LATE 2008 - 2009. DIAGNOSIS OR REASON FOR USE: CONTACT LENS DISINFECTION. EVENT ABATED AFTER USE STOPPED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYSEPT ULTRACARE FORMULA NONE LPN ADVANCED MEDICAL OPTICS ZC04881

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other