BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS NIGHT & DAY

    MDR report key: 1422937 · Received July 24, 2009

    Report

    Report Number
    9681121-2009-00010
    Event Type
    Injury
    Date Received
    July 24, 2009
    Date of Event
    June 3, 2009
    Report Date
    June 8, 2009
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PATIENT REPORTED BEING TREATED FOR AN INFECTION, RIGHT EYE, ASSOCIATED WITH WEAR OF FOCUS NIGHT & DAY CONTACT LENSES. FOLLOW UP INFORMATION WAS RECEIVED FROM THE TREATING EYE CARE PROFESSIONAL ON 06/30/2009. PATIENT PRESENTED IN 2009, WITH SEVERE PAIN & LIGHT SENSITIVITY. DIAGNOSED AS BACTERIAL KERATITIS, 1.5 X 2MM LOCATED AT 10 O'CLOCK PERIPHERAL CORNEA. INITIAL TREATMENT ZYMAR Q2D THEN REDUCED. NEXT DAY FOLLOW UP - SOME IMPROVEMENT, PAIN DECREASED, LIGHT SENSITIVITY IMPROVED, INFILTRATE LESS DENSE 1X1.5MM. ZYMAR Q3H OD. CILOXAN OP HUNG QHS OD. ONE GTT PREFORTE OD IN OFFICE. AT 3 DAYS FOLLOW UP VISIT - FEELING BETTER, MINIMAL PAIN, MILD LIGHT SENSITIVITY. NO CORNEAL EDEMA, NO STAINING, NO EPITHELIAL DEFECT. FADING INFILTRATE, MUCH IMPROVED. ZYMAR QID OD. CILOXAN OPH UNG QHS OD. AT ABOUT 7 DAYS FOLLOW UP VISIT - MUCH IMPROVEMENT, NO PAIN, NO LIGHT SENSITIVITY. IRRITATION & BURNING OD, ALMOST RESOLVED. ZYMAR TID OD, CILOXAN OP HUNG QHS OD. AT ABOUT ONE WEEK FOLLOW UP VISIT - BURNING & IRRITATION OD, NO PAIN. NO EVIDENCE OF SCAR OF INFILTRATE OD. RESOLVED. DISCONTINUE ZYMAR, CONTINUE CILOXAN QHS. AT APPROXIMATELY 8 DAYS FINAL VISIT - RESOLVED WITH NO REDUCTION OF VISUAL ACUITY. DISCONTINUE CILOXAN. ADVISED TO WEAR CL ON REDUCED TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED.