BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS DAILIES

    MDR report key: 674181 · Received January 30, 2006

    Report

    Report Number
    1065835-2006-00002
    Event Type
    Injury
    Date Received
    January 30, 2006
    Date of Event
    December 31, 2005
    Report Date
    January 13, 2006
    Manufacturer
    CIBA VISION CORPORATION
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN EYE CARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED SEVERE PAIN IN HIS RIGHT EYE ASSOCIATED WITH WEAR OF FOCUS DAILIES CONTACT LENSES. CORNEAL ULCER (2MM), CENTRALLY LOCATED, NOTED. VIGAMOX RX'D. PRE-EVENT ACUITY 20/20, LAST REPORTED 20/40 OD. EVENT RESOLVED WITH 1MM SCAR REMAINING. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS DAILIES SOFT CONTACT LENS LPL CIBA VISION CORPORATION NA 4327025

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention