BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE MULTIPURPOSE EASY RUB FORMULA

    MDR report key: 1220369 · Received October 31, 2008

    Report

    Report Number
    2020664-2008-00054
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE COMPLAINT UNIT SHOWS THE SOLUTION CONTAINS A LATHERED PRODUCT WITH A SMELL OF MINT, AND A BLUE COLOR. RETAINED SAMPLE MEETS PHYSICO-CHEMICAL SPECIFICATIONS.

    Description of Event or Problem · 1

    MALE REPORTS HIS EYES BEGAN TO BURN AFTER USING HIS TRAVEL SIZE OF COMPLETE MULTIPURPOSE EASY RUB FORMULA WITH HIS RIGID GAS PERMEABLE CONTACT LENSES. HE WAS OUT OF TOWN AND THOUGHT THIS CONTRIBUTED TO THE EVENT. HE TRIED THE PRODUCT AGAIN WHEN HE RETURNED HOME, AND EXPERIENCED THE SAME SYMPTOM. WHEN ASKED IF HE REFILLED HIS TRAVEL SIZE BOTTLE FROM THE 12 OZ BOTTLE OF SOLUTION, HE SAYS HE DID NOT, BUT ADMITTED TO DO SO IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MULTIPURPOSE EASY RUB FORMULA LPN ADVANCED MEDICAL OPTICS, INC. NA AC04573

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR RIGID GAS PERMEABLE CONTACT LENSES (BRAND UNK)