BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 3252111 · Received July 24, 2013

    Report

    Report Number
    9681121-2013-00008
    Event Type
    Injury
    Date Received
    July 24, 2013
    Report Date
    June 28, 2013
    Manufacturer
    CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE LOT 31063092 MET ALL IN-PROCESS AND FINISHED PRODUCT SPECIFICATIONS. THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HER CONTACT LENS CAUSED IRRITATION AND A CORNEAL ULCER. MEDICAL ATTENTION WAS SOUGHT, AND THE CONSUMER WAS PRESCRIBED VIGAMOX FOR TREATMENT. THE CONSUMER STATED THAT THE ISSUE IS RESOLVING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344742 AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT, EXTENDED WEAR LPM CIBA VISION BATAM 31063092

    Patients

    Seq Age Sex Outcome Treatment
    1 Other