BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMO COMPLETE MOISTURE PLUS

    MDR report key: 946551 · Received November 6, 2007

    Report

    Report Number
    MW5004358
    Event Type
    Other
    Date Received
    November 6, 2007
    Date of Event
    November 3, 2007
    Report Date
    November 6, 2007
    Manufacturer
    AMO
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER IS A USER OF CONTACT LENSES. IN 2007, THE PT STARTED WITH SEVERE PAIN IN THE RIGHT EYE. AFTER 10 HRS OF PAIN, THE EYE WAS SWOLLEN AND THE PT COULD NOT OPEN THE EYES. THE AREA WAS COMPLETELY RED AND IRRITATED. ON TWO DAYS LATER, THE PT WAS TAKEN TO THE OPHTHALMOLOGIST AND THE DR CONFIRMED THAT PT HAD A ULCER AND WAS SUFFERING OF CORNEAL INFECTION. THE PT WAS USING AMO COMPLETE MOISTURE PLUS WHICH WAS PURCHASED FROM A PHARMACY WEEKS AGO AS WELL AS THE CLEANING SOLUTION. PATIENT INFORMED HAVING BLURRY VISION. THE PT CONTINUES WITH TREATMENT WITH THE DR. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: CONTACT LENSES USER. CONTACT LENSES USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO COMPLETE MOISTURE PLUS NONE LPN AMO AB04225
    2 AMO COMPLETE MULTI-PURPOSE NONE LPN AMO AC02937

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other