BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 1910431 · Received November 18, 2010

    Report

    Report Number
    9681121-2010-00042
    Event Type
    Injury
    Date Received
    November 18, 2010
    Report Date
    October 19, 2010
    Manufacturer
    PT. CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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 FOLLOW-UP MEDWATCH WILL BE FILED. (B)(4) .

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE EYE CARE PROFESSIONAL THAT THE PT EXPERIENCED A CORNEAL ULCER FOLLOWING CONTACT LENS USE. THE EYE CARE PROFESSIONAL STATED THE ISSUE HAS RESOLVED. ADDITIONAL INFO RECEIVED ON (B)(6) 2010, BY THE EYE CARE PROFESSIONAL STATED THAT DURING FOLLOW-UP EXAMINATION ON (B)(6) 2010, THE ISSUE HAD RESOLVED AND THE PT HAS RETURNED TO SUCCESSFUL CONTACT LENS USAGE. THE PT EXPERIENCED SEVERE PAIN. ADDITIONAL INFO RECEIVED ON (B)(6) 2010, STATED THAT THE EVENT OCCURRED ON (B)(6) 2010, IN THE PT'S RIGHT EYE. THE PT EXPERIENCED ONE CENTRAL INFILTRATE AND TWO PERIPHERAL INFILTRATES. THE PT WAS DIAGNOSED WITH A CORNEAL ULCER IN THE RIGHT EYE AND TREATED WITH BESIVANCE AND VANCOMYCIN ALTERNATE EVERY HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT LPM PT. CIBA VISION BATAM 959006

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other