BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX AQUA

    MDR report key: 2080621 · Received April 25, 2011

    Report

    Report Number
    3006186389-2011-00007
    Event Type
    Injury
    Date Received
    April 25, 2011
    Report Date
    March 26, 2011
    Manufacturer
    CIBA VISION JOHORE SDN. BHD
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE FROM THE SAME LOT WAS EVALUATED AND FOUND TO BE OUT OF SPECIFICATION FOR SURFACE FRACTURE. AN INVESTIGATION IS UNDERWAY BY MANUFACTURING. IF ANY ABNORMALITY IS FOUND, A FOLLOW UP REPORT WILL BE PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON A PRODUCT RETURN FORM BY THE EYE CARE PROFESSIONAL THAT A PATIENT EXPERIENCED A MEDICAL COMPLAINT. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT DEVELOPED SEVERAL INFILTRATES AND A NON-INFECTIOUS CENTRAL CORNEAL ULCER IN HIS RIGHT EYE. THE PATIENT WAS TREATED WITH VIGAMOX AND THE PATIENT'S ULCER RESOLVED AFTER 10 DAYS. THE PATIENT'S INFILTRATES RESOLVED WITHIN 3 WEEKS FROM ONSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OPTIX AQUA LENSES, SOFT CONTACT, EXTENDED WEAR LPM CIBA VISION JOHORE SDN. BHD 10032817

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other