BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS NIGHT & DAY

    MDR report key: 464255 · Received June 5, 2003

    Report

    Report Number
    9681121-2003-00020
    Event Type
    Injury
    Date Received
    June 5, 2003
    Date of Event
    May 12, 2003
    Report Date
    May 15, 2003
    Manufacturer
    P.T. CIBA VISION BATAM
    Product Code
    LPM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM AN OPTOMETRIST THAT A PATIENT HAD EXPERIENCED SEVERE PAIN AND LOSS OF VISUAL ACUITY IN THE LEFT EYE IN 05/2003 ASSOCIATED WITH WEAR OF FOCUS NIGHT & DAY LENSES ON A CONTINUOUS WEAR BASIS FOR SEVERAL DAYS. THE PATIENT SOUGHT CARE AT LOCAL HOSPITAL EMERGENCY ROOM ON THAT DAY. OUTCOME OF VISIT UNKONWN OTHER THAN OCUFLOX WAS ADMINISTERED BY ER PHYSICIAN. IN 05/2003, PATIENT PRESENTED TO REPORTING OPTOMETRIST'S OFFICE. CENTRAL CORNEAL ULCER, PRESUMED TO BE INFECTIOUS, WITH VISUAL ACUITY OF 20/200 DIAGNOSED IN LEFT EYE. MODERATE CELLS AND FLARE NOTED, CONJUNCTIVA 2 + INJECTION. REFERRED TO CORNEAL SPECIALIST SAME DAY. CULTURE AND SCRAPING PERFORMED. TOBRAMYCIN, CEFAZOLIN, CILOXAN & GENTAMYCIN PRESCRIBED. AT FOLLOW UP VISIT A FEW DAYS LATER, THE EPITHELIUM HAD COVERED OVER THE ULCER. CORTICOSTEROID ADDED TO TREATMENT PLAN. AS OF 05/2003, MD REPORTS CULTURE POSITIVE FOR PSEUDOMONAS AERUGINOSA. CORNEA HAS RE-EPITHELIALIZED AND VISUAL ACUITY REPORTED AT 20/25 IN LEFT EYE WITH SMALL CENTRAL <1MM SCAR. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS NIGHT & DAY EXTENDED WEAR SOFT CONTACT LENS LPM P.T. CIBA VISION BATAM NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention NONE REPORTED.