BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 2010578 · Received March 1, 2011

    Report

    Report Number
    9681121-2011-00010
    Event Type
    Injury
    Date Received
    March 1, 2011
    Report Date
    February 7, 2011
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPT TO OBTAIN THE COMPLAINT SAMPLE HAS BEEN UNSUCCESSFUL. IF THE DEVICE IS MADE AVAILABLE FOR ANALYSIS AND/OR ADDITIONAL INFO HAS BEEN PROVIDED, A FOLLOWING MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY A CONSUMER THAT THEY EXPERIENCED EYE INFECTIONS FOLLOWING CONTACT LENS USE. NUMEROUS ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other