BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMO COMPLETE MOISTURE PLUS

    MDR report key: 707321 · Received April 13, 2006

    Report

    Report Number
    MW1038633
    Event Type
    Other
    Date Received
    April 13, 2006
    Date of Event
    April 9, 2006
    Report Date
    April 13, 2006
    Manufacturer
    ADVANCED MEDICAL
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SOFT CONTACT LENS USER, DEVELOPED KERATITIS INFECTION ON 4/09/06, ULCERATED 3MM IN RIGHT EYE ONLY. CONTACT LENS: ACUVUE ADVANCE WITH HYDRACLEAR- LOT B003W5Z46M- LENS SOLUTION: AMO COMPLETE MOISTURE PLUS- LOT AA02913- AND AMO ULTRACARE 33755. LENS DROPS: ALCON CLERZ PLUS- 86287F- SYMPTOMS: NEAR TOTAL VISION LOSS- EVENTUALLY REGAINED 4/12/06, BURNING, INFLAMED EYELID, EXTREME REDNESS, LIGHT-SENSITIVITY. DRUGS: ALLEGERAN ZYMAR-GATIFLOXACIN OPHTHAMALIC SOLUTION- LOT 42423 ALTAIRE HOMATROPAIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO COMPLETE MOISTURE PLUS * LPN ADVANCED MEDICAL * AA02913
    2 AMO ULTRACARE * LPN ADVANCED MEDICAL * *
    3 ALCON CLERZ PLUS * LPN ALCON * *
    4 ACUVUE ADVANCE WITH HYDRACLEAR * LPL * * B003W5Z46M

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other