BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 1885963 · Received October 13, 2010

    Report

    Report Number
    9681121-2010-00037
    Event Type
    Injury
    Date Received
    October 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORT WAS REDACTED, NO FOLLOW-UP EVENT IS POSSIBLE. (B)(4).

    Description of Event or Problem · 1

    THIS IS THE FIRST OF THREE REPORTS ON THE SAME EVENT INVOLVING THREE PRODUCTS. REFER TO MEDWATCH 8020392-2010-00015 FOR A DESCRIPTION OF THE SECOND REPORT. REFER TO MEDWATCH 8020392-2010-00016 FOR A DESCRIPTION OF THE THIRD REPORT. (B)(4): PATIENT IS A FEMALE WHO WAS ENROLLED IN A CONTACT LENS STUDY IN 2010, INVOLVING ONLY MARKETED CONTACT LENSES AND LENS CARE PRODUCTS. SHE WAS DISPENSED THE CIBA VISION AIR OPTIX NIGHT & DAY LENSES, CIBA VISION CLEAR CARE LENS CARE, CIBA VISION AQUIFY LENS COMFORT DROPS, AND ALCON UNISOL SALINE. SHE SUCCESSFULLY COMPLETED ONE MONTH OF WEAR. WHILE ON VACATION, SHE DEVELOPED RAPIDLY PROGRESSING SYMPTOMS OF A CORNEAL ULCER IN HER LEFT EYE. SHE DID NOT SEEK TREATMENT, ADVICE OR CONTACT A DOCTOR UNTIL SHE RETURNED HOME ON SUNDAY NIGHT WHEN SHE PRESENTED TO THE HOSPITAL EMERGENCY ROOM. SHE WAS ADMITTED OVERNIGHT, CULTURED AND AGGRESSIVELY TREATED AT THAT FACILITY. CORRESPONDENCE WITH THE OPHTHALMOLOGISTS ON STAFF NOTED A PSEUDOMONAS CORNEAL ULCER -ABOUT 5 MM- IN THE 9:00-12:00 QUADRANT OF HER LEFT CORNEA INVOLVING HER VISUAL AXIS. THE PATIENT TRANSFERRED HER TREATMENT TO OUR FACILITY UNDER THE CARE OF A CORNEAL SPECIALIST. THE ULCER WAS IMPROVING BUT NOT RESOLVED. IT EPITHELIALIZED. CURRENTLY, HER VISION IS 201100 WHICH IMPROVES WITH PINHOLES AND SQUINTING. SHE CONTINUES TO BE MONITORED.

    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 9644125

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R