BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS VISITINT

    MDR report key: 337273 · Received June 14, 2001

    Report

    Report Number
    9681121-2001-00007
    Event Type
    Injury
    Date Received
    June 14, 2001
    Date of Event
    March 5, 1996
    Report Date
    June 7, 2001
    Manufacturer
    P.T. CIBA VISION BATAM
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SERIOUS INJURY INVOLVING ONE PERSON. THE EVENT WAS REPORTED TO CIBA VISION VIA THE PT'S OPTICIAN IN 2001. 1996-THE PT STARTED USING FOCUS VISITINT AND SOLO CARE. 2 MONTHS LATER AN ULCER WAS DETECTED IN THE PT EYES ALONG WITH DRY EYE SYNDROME. DURING NEXT 13 DAYS THE ULCER DEVELOPED TO LEUCOMA. FOR THE LENSCARE REPORT REFER TO MFR REPORT# 8020392-2001-0001 REGARDING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27174 FOCUS VISITINT SOFT CONTACT LENS LPL P.T. CIBA VISION BATAM NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other