BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O2OPTIX

    MDR report key: 1080386 · Received July 22, 2008

    Report

    Report Number
    9681121-2008-00014
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 25, 2008
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WAS REVIEWED BY THE CIBA VISION MEDICAL MONITOR WITH THE FOLLOWING CONCLUSION: "THIS CASE IS CONSIDERED AS IRITIS." AS THERE WAS NO PRODUCT RETURNED OR LOT INFO PROVIDED, NO DETAILED INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT A PT WORE O2OPTIX CONTACT LENSES FOR 2 DAYS, THEN REMOVED & DISCARDED. UPON AWAKENING THE FOLLOWING MORNING, SHE EXPERIENCED PAIN, REDNESS & CORNEAL EDEMA, RIGHT EYE. CARE WAS SOUGHT FROM OPTOMETRIST, WHO CONSULTED WITH AN OPHTHALMOLOGIST. ZYLET PRESCRIBED. NO IMPROVEMENT NEXT DAY, CHANGED RX TO VIGAMOX FOR 24 HRS. NO IMPROVEMENT NEXT DAY. REFERRED TO OPHTHALMOLOGIST SAME DAY FOR SUSPECTED IRITIS. FOLLOW UP 2 DAYS LATER, WITH OPTOMETRIST WHO NOTED SOME IMPROVEMENT WITH NO REDNESS OR SWELLING. FOLLOW UP VISIT SCHEDULED IN 10 DAYS. OPTOMETRIST NOTED PT DID HAVE A LENS IN THE EYE WHICH HE THOUGHT HAD BEEN UNDER THE EYELID FOR SEVERAL DAYS & HAD RECENTERED ON THE CORNEA DUE TO USE OF LENS DROPS. OPTOMETRIST CONFIRMED DIAGNOSIS OF IRITIS (MINIMAL CELLS & FLARE) & THAT TREATMENT INCLUDED A STEROID (PRED FORTE). EVENT RESOLVED AND LENS WEAR HAS RESUMED. NO FURTHER INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O2OPTIX SOFT CONTACT LENS LPM PT CIBA VISION BATAM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED