BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIBA FOCUS NIGHT AND DAY

    MDR report key: 404692 · Received July 10, 2002

    Report

    Report Number
    MW1025551
    Event Type
    Other
    Date Received
    July 10, 2002
    Date of Event
    June 21, 2002
    Report Date
    July 2, 2002
    Manufacturer
    CIBA VISION CORP
    Product Code
    LPM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT INSERTED TRIAL SET OF CIBA FOCUS NIGHT AND DAY CONTACT LENSES, BOTH PWR -3.00, BC=8.6, DIAM=13.8. ONE HAD LOT NO 2424154, THE OTHER HAD LOT NO 2422129. THE PT'S RIGHT PUPIL DILATED SHORTLY AFTER INSERTION OF LENS. LENSES WERE REMOVED. PUPIL REMAINED DILATED FOR APPROX 10 HRS. RETURNED TO NORMAL THEN.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 7/17/02: THIS APPEARED TO BE MYDRIASIS DUE TO PHARMACOLOGIC DILATION. FOLLOW UP VIA TELEPHONE WITH THE PT AND PARENT INDICATED THAT THE PUPIL RETURNED TO NORMAL AFTER ABOUT TEN HRS. RPTR BELIEVES THAT IT IS A POSSIBILITY THAT THERE COULD BE A MYDRIATIC AGENT CONTAMINATING ONE OF THESE CONTACT LENSES. UNFORTUNATELY, THE PT WEARS THE SAME PRESCRIPTION IN BOTH EYES AND SO RTPR DOESN'T KNOW WHICH LOT NUMBER LENS WAS INSERTED INTO RIGHT EYE, BUT IF IT IS CONTAMINANT IN THE CONTACT LENS OR PACKAGED SOLUTION, THEN IT WOULD HAVE TO HAVE BEEN IN ONE OF THE TWO LOT NUMBERS MENTIONED. FACTORS THAT LIMIT RPTR'S CERTAINTY ABOUT THE CASE ARE THAT THEY WERE NOT THE ONE TO INSERT THE CONTACT LENSES. THE PT WAS IN THE ROOM WITH THEIR PARENT AND REPORTS THAT THEY TOOK THE LENSES DIRECTLY FROM THE PACKAGE AND INSERTED THEM INTO THEIR EYE. RPTR HAS MYDRIATIC AGENTS IN THE OFFICE, BUT DOESN'T THINK THAT THE PT WOULD HAVE CONTAMINATED THEIR FINGER OR THE CONTACT LENS WITH ANY OF THESE SOLUTIONS. RPTR HAS SAVED THE CONTACT LENS PACKAGING WITH REMAINING SOLUTION AS WELL AS THE CONTACT LENSES THAT WERE CONTAINED IN THOSE PACKAGES STORED IN A CASE WITH CONTACT LENS STORAGE SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIBA FOCUS NIGHT AND DAY EXTENDED WEAR CONTACT LENS LPM CIBA VISION CORP CIBA FOCUS NIGHT & DAY 2424154
    2 CIBA FOCUS NIGHT & DAY EXTENDED WEAR CONTACT LENS LPM CIBA VISION CORP CIBA FOCUS NIGHT & DAY 2422129

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other