BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCUSOFT LID SCRUB

    MDR report key: 1812173 · Received August 4, 2010

    Report

    Report Number
    MW5017150
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 23, 2010
    Manufacturer
    OCUSOFT INC.
    Product Code
    HOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FIRST THE SLIGHT BURNING OF EYE AND SURROUNDING TISSUE. STOPPED USING FOR 1 WEEK. SECOND TO 11TH USE NO PROBLEMS. ELEVENTH PRE-MOISTENED PAD FROM PACKET 11 CAUSED SEVERE ALL NIGHT BURNING OF ALL SURROUNDING EYE TISSUE, ESPECIALLY RIGHT UNDER EYE WHICH HURT AND PEELED FOR 6 DAYS. IN MY OPINION, THIS PRODUCT IS UNSTABLE AND IS NOT UNIFORMALLY FORMULATED (IT'S NOT THE SAME IN ALL PACKETS). I CONSIDER THIS PRODUCT TO BE EXTREMELY DANGEROUS AND COULD POSSIBLY CAUSE BLINDNESS. IT SHOULD BE TAKEN OFF THE MARKET. WHEN I CALLED OCUSOFT INC., THEY ACTED LIKE I WAS LOOKING FOR A REFUND. IF THIS WAS THE CASE, I COULD HAVE RETURNED PRODUCT TO THE DRUG STORE. DOSE OR AMOUNT: PRE-MOISTENED PADS. FREQUENCY: DATES OF USE: (B)(6) - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: CLEANSING OF EYE LIDS. EVENT ABATED AFTER USE: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCUSOFT LID SCRUB EYELID CLEANSER HOZ OCUSOFT INC. 8138

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other