BEUDAMED
    FDA Adverse Event Other Summary report: N

    RENU WITH MOISTURELOC

    MDR report key: 722096 · Received June 1, 2006

    Report

    Report Number
    MW1039427
    Event Type
    Other
    Date Received
    June 1, 2006
    Date of Event
    May 26, 2006
    Report Date
    June 1, 2006
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT RELATES TO USE OF BAUSCH & LOMB'S "RENU WITH MOISTURELOC" MULTI-PURPOSE SOLUTION. PT HAD A 4 FL. OZ. SAMPLE FROM LAST EYE DOCTOR VISIT IN MARCH 2006 WHICH HE OPENED (TRACKED THE NECKBAND ON BRAND NEW PRODUCT WITH 2007-11 EXPIRATION DATE) ON WEDNESDAY, MAY 24, 2006. PT STORED HIS CONTACT LENSES IN SOLUTION FOR ABOUT 7 HOURS PER NIGHT FOR TWO CONSECUTIVE NIGHTS. FRIDAY EVENING MAY 26, 2006 PT FELT A DEEP PAIN UNDER LEFT EYE, AT WHICH POINT HE DISCONTINUED CONTACT LENSS WEAR, BY EVENING OF MAY 27TH PAIN WAS SUBSIDING AND WAS ALMOST IMPERCEPTIBLE BY MAY 28TH, AT WHICH POINT A VISIBLE, THOUGH MINOR SWELLING DEVELOPED ON THE RIM OF THE LOWER LEFT EYELID. SWELLING HAS BEEN GRADUALLY SUBSIDING THROUGH AND INCLUDING TUESDAY, MAY 30TH. WHAT CURRENTLY REMAINS IS A TINY WHITE INDENTATION ON THE RIM OF THE LOWER LEFT EYELID REMINISCENT OF (RECOVERY FROM) AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU WITH MOISTURELOC * LPN BAUSCH & LOMB * GL5007

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other