BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 2191126 · Received July 29, 2011

    Report

    Report Number
    9681121-2011-00027
    Event Type
    Injury
    Date Received
    July 29, 2011
    Report Date
    June 30, 2011
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT O2 OPTIX LENS IS CONSIDERED A (B)(4) ONLY PRODUCT NAME. IT IS THE SAME LENS AS AIR OPTIX NIGHT & DAY AQUA. THE ACTUAL PLACE OF MFR COULD NOT BE DETERMINED. NO DEVICE IS AVAILABLE FOR EVAL AND NO MFG INVESTIGATION CAN BE PERFORMED AS LOT NUMBER IS UNK. (B)(4).

    Description of Event or Problem · 1

    JOHNSON & JOHNSON VISION CARE REPORTED TO CIBA VISION THAT TWO PT'S HAD DEVELOPED ACANTHAMOEBA KERATITIS. (ONE PT WITH MEDICAL DEVICE FROM J & J AND THE OTHER FROM CIBA VISION). THE INFO WAS OBTAINED FROM LITERATURE: THREESOME 2011 IN KYOTO - PROGRAM AND ABSTRACT - PAGE 54, GK-16. SUBJECT: TWO CASES OF ACANTHAMOEBA KERATITIS WITH SILICONE HYDROGEL SCL. THIS CASE IS DESCRIBED IN THE EXTRACT OF THE (B)(4) FOR OCULAR INFECTION. PT'S INITIAL SYMPTOM WAS A (B)(6) SENSATION IN THE RIGHT EYE (B)(6) 2010. WHEN THE SYMPTOM DID NOT IMPROVE THE PT WAS REFERRED TO AN (B)(4) MEDICAL CENTER WHERE HE WAS SUSPECTED OF ACANTHAMOEBA KERATITIS. THE PATIENT'S VISUAL ACUITY HAD NOT IMPROVED SO HE WAS REFERRED TO A HOSPITAL WHERE HE WAS PRESCRIBED ANTIFUNGAL AND ANTISEPTIC MEDICATIONS. THE PT'S VISUAL ACUITY HAD IMPROVED AND PT WAS DISCHARGED FROM THE HOSPITAL. ADD'L INFO WAS OBTAINED FROM THE PHYSICIAN INDICATING THE PT HAD BEEN USING THE O2 OPTIX AND "SOFTCON", A SOLUTION FOR SOFT CONTACT LENS. AFTER THE PT LEFT THE HOSPITAL HE HAD A RELAPSE OF ACANTHAMOEBA KERATITIS AND WAS RE-ADMITTED TO THE HOSPITAL. THE DOCTOR CONFIRMED THE PT HAD RECOVERED BUT VISUAL ACUITY IS UNK.

    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 62 YR Hospitalization| O