BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX FOR ASTIGMATISM

    MDR report key: 1910430 · Received November 18, 2010

    Report

    Report Number
    9681121-2010-00045
    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
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY THIS MFR, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. UPON 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

    IT WAS INITIALLY REPORTED BY THE EYE CARE PROFESSIONAL THAT THE PT WAS DIAGNOSED WITH AN INFILTRATE IN HIS EYE FOLLOWING CONTACT LENS USE. ADDITIONAL INFO RECEIVED ON (B)(6) 2010 FROM THE EYE CARE PROFESSIONAL STATED THAT THE PT WAS DIAGNOSED WITH "INFILTRATIVE KERATITIS." THERE WERE 5 - 6 INFILTRATES LOCATED MIDPERIPHERAL AND CENTRAL IN EACH EYE WITH STAINING PRESENT FOR ONLY TWO OF THE INFILTRATES IN HIS LEFT EYE. NO STAINING WAS PRESENT IN THE RIGHT EYE. THE PT WAS TREATED WITH VIGAMOX. THE PT HAS NOT EXPERIENCED ANY VISION LOSS. ADDITIONAL INFO RECEIVED ON (B)(6) 2010 FROM THE EYE CARE PROFESSIONAL STATED THAT THE PT HAS BEEN RELEASED FROM CARE AND THE CORNEA HAS COMPLETELY HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACT LPM PT. CIBA VISION BATAM 04900902015020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other