BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS DAILIES

    MDR report key: 1970337 · Received January 14, 2011

    Report

    Report Number
    1065835-2011-00001
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    September 1, 2010
    Report Date
    December 17, 2010
    Manufacturer
    CIBA VISION
    Product Code
    MVN
    PMA / PMN Number
    K984273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT EXPERIENCED A CENTRAL CORNEAL ULCER, LEFT EYE, ASSOCIATED WITH WEAR OF FOCUS DAILIES CONTACT LENSES. FOLLOW UP INFORMATION RECEIVED FROM THE TREATING EYE CARE PROFESSIONAL ON (B)(6) 2011, INDICATES THE PATIENT EXPERIENCED MODERATE PAIN ASSOCIATED WITH A CORNEAL ULCER, LOCATED CENTRAL CORNEA, 1MM IN SIZE, AND WAS TREATED WITH TOPICAL ANTIBIOTICS. EVENT IS STABLE WITH CURRENT VISUAL ACUITY NOTED AS 8/10. PRE-EVENT ACUITY NOTED AS 10/10 PRE-EVENT. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS DAILIES LENSES, SOFT CONTACT, DAILY WEAR MVN CIBA VISION A0157526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED