BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCUSOFT LID SCRUB

    MDR report key: 11018879 · Received December 15, 2020

    Report

    Report Number
    MW5098382
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    December 11, 2020
    Report Date
    December 12, 2020
    Manufacturer
    OCUSOFT INC.
    Product Code
    HOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I OPENED A NEW BOX OF OCUSOFT LID SCRUBS, A PRODUCT I HAVE USED FOR MANY YEARS TO CONTROL BLEPHARITIS SYMPTOMS. THE SCRUBS WERE NOT FOLDED IN HALF AS USUAL AND INSTEAD WERE FOLDED PARTWAY OVER, CAUSING THEM TO BE BUNCHED UP IN THE WRAPPER. I USE THEM ANYWAY AND HAD BURNING SORE AND RED EYES THAT DAY. APPARENTLY THERE WAS SOMETHING CONTAMINATING THE SCRUBS BECAUSE AFTER I USED THEM TWO DAYS LATER MY EYES AND THE LIDS BURNED AGAIN. EVEN AFTER SHOWERING THE BURNING PERSISTED AND EVEN WORSENED THROUGHOUT THE DAY. THE DISCOMFORT LASTED FOR THE ENTIRE DAY AND THE FOLLOWING NIGHT. I DEVELOPED A HEADACHE AS WELL. I DECIDED TO BUY A NEW BOX FROM A DIFFERENT SOURCE, AND WHEN I OPENED THE BOX I FOUND THE SAME ODD FOLD AND BUNCHED UP APPEARANCE IN THE WRAPPER. I WAS AFRAID TO TRY TO USE THE PRODUCT AGAIN. I HAVE PURCHASED A DIFFERENT BRAND INSTEAD. THE PRODUCT HAS ALWAYS BEEN EXCELLENT IN THE PAST BUT THE TWO BOXES I HAVE NOW ARE DEFINITELY CONTAMINATED IN SOME WAY AND SHOULD BE RECALLED. THE LOT NUMBERS ARE 1605 (THE ONE THAT CAUSED A SEVERE REACTION) AND 1029, THE REPLACEMENT I BOUGHT THAT SHOWED SIMILAR PROBLEMS WITH PACKAGING. APPLIED TO THE EYE LID FOR BLEPHARITIS. ORIGINAL EYELID CLEANSER FOR MILD-MODERATE CONDITION. (B)(4). MULTIPLE EYE SURGERIES OVER LIFETIME; BLEPHARITIS TREATED WITH ANTIBIOTIC 3 TIMES A WEEK AT BEDTIME AND LID SCRUB USED IN THE MORNING TO REMOVE DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474952 OCUSOFT LID SCRUB EYELID CLEANSER HOZ OCUSOFT INC. 1605
    1474953 OCUSOFT LID SCRUB EYELID CLEANSER HOZ OCUSOFT INC. 1029

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other