BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX

    MDR report key: 2250684 · Received September 12, 2011

    Report

    Report Number
    MW5022240
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    September 12, 2011
    Report Date
    September 12, 2011
    Manufacturer
    CIBA VISION
    Product Code
    LPL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4). DATE OF USE: #1 AND #2: (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: MYOPIA. EVENT ABATED AFTER USE STOPED OR DOSE REDUCED #1 AND #2: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OPTIX SIHI CONTACT LENS LPL CIBA VISION
    2 BIOTRU CONTACT LENS SOLUTION LPN BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Disability BAUSCH & LOMB BIOTRUE