BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 1773076 · Received July 9, 2010

    Report

    Report Number
    9681121-2010-00017
    Event Type
    Other
    Date Received
    July 9, 2010
    Report Date
    June 10, 2010
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THERE WAS NO PRODUCT RETURNED OR LOT INFO PROVIDED, NO DETAILED INVESTIGATION CAN BE PERFORMED. ADD'L MFR NARRATIVE. LIMITED AND/OR LACK OF DETAILED INFO IS KNOWN FOR THIS EVENT, THEREFORE IT IS CONSIDERED TO BE SERIOUS AND REPORTABLE, AS A POSSIBLE PERMANENT REDUCTION IN VISUAL ACUITY. (B)(4).

    Description of Event or Problem · 1

    REDACTED MEDWATCH #(B)(4) REC'D. THE CONSUMER REPORTED A 20 YEAR SUCCESSFUL LENS WEAR HISTORY, MOST RECENTLY WITH FOCUS NIGHT AND DAY LENSES. HE RECENTLY CHANGED TO NEWER VERSION, AIR OPTIX NIGHT AND DAY AQUA. SINCE WEARING THE NEW VERSION, HE REPORTS "MY EYES BECAME RED, SWOLLEN, DRY, AND VERY IRRITATED. AFTER RULING OUT OTHER EXTERNAL FACTORS, IT WAS DETERMINED THAT THE LENSES THEMSELVES WERE CAUSING THE IRRITATION. SINCE THEN, MY VISION HAS BECOME BLURRY AND I HAVE BEEN DIAGNOSED WITH THYGESON'S DISEASE AND I CANNOT SEE CLEARLY DUE TO THESE CORNEAL LESIONS." EVENT REQUIRED UNSPECIFIED INTERVENTION. EVENT ABATED AFTER USE.

    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 NONE REPORTED