BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES VISITINT

    MDR report key: 1940616 · Received December 22, 2010

    Report

    Report Number
    9610813-2010-00010
    Event Type
    Injury
    Date Received
    December 22, 2010
    Report Date
    October 20, 2010
    Manufacturer
    CIBA VISION GMBH
    Product Code
    LPL
    PMA / PMN Number
    K984273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE IS CONSIDERED AS A POSSIBLE INFECTIOUS KERATITIS. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A FOLLOW-UP MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    A CONTACT LENS WEARER REPORTED THAT 5 DAILIES AQUACOMFORT PLUS CONTACT LENSES HAD TORN DURING WEAR AND/OR DURING INSERTION OR REMOVAL. FOLLOW UP INFO RECEIVED ON (B)(6)2010, INDICATED THAT THE PT WAS DIAGNOSED WITH A KERATITIS IN THE LEFT EYE. TREATMENT CONSISTED OF FLOXAL MEDICATION (NOT SPECIFIED IF EYE DROPS OR EYE OINTMENT) TO BE APPLIED TWO-HOURLY AND WAS ADVISED TO DISCONTINUE CONTACT LENS WEAR UNTIL FOLLOW-UP VISIT SCHEDULED FOR (B)(4) 2011. NO FURTHER INFO HAS BEEN MADE AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILIES VISITINT DAILY WEAR SOFT CONTACT LENS LPL CIBA VISION GMBH N0035581

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED.