BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT AND DAY AQUA

    MDR report key: 1940630 · Received December 22, 2010

    Report

    Report Number
    9681121-2010-00056
    Event Type
    Injury
    Date Received
    December 22, 2010
    Report Date
    December 8, 2010
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A F/U MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    THE PT POSTED IN AN INTERNET BLOG ON (B)(6) 2010 THAT FOLLOWING APPROXIMATELY FOUR WEEKS OF CONTACT LENS WEAR, HE EXPERIENCED RED, PAINFUL, BURNING EYES THAT CAUSED HIM TO SEEK MEDICAL ATTENTION. THE PT STATED THAT HE WAS BEING TREATED WITH VIGAMOX EYE DROPS FOUR TIMES PER DAY IN BOTH EYES FOR INFECTIONS. THE INTERNET BLOG POSTING WAS READ BY THE DEVICE MFR ON (B)(4) 2010. THIS EVENT WAS IDENTIFIED FROM AN INTERNET BLOG. NO CONTACT INFO WAS PROVIDED, THEREFORE NO FURTHER F/U CAN BE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other