BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 4579251 · Received March 6, 2015

    Report

    Report Number
    9610813-2015-00504
    Event Type
    Injury
    Date Received
    March 6, 2015
    Date of Event
    February 18, 2015
    Report Date
    March 25, 2015
    Manufacturer
    CIBA VISION GMBH
    Product Code
    LPL
    PMA / PMN Number
    K113168
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. THERE WAS NO NONCONFORMITY OR DEVIATIONS DURING THE MANUFACTURING PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION AT THIS TIME. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT ON (B)(6) 2015, SHE WAS DIAGNOSED WITH A CORNEAL ULCER. ADDITIONAL INFORMATION RECEIVED FROM THE TREATING EYE CARE PROFESSIONAL ON (B)(6) 2015 INDICATED THAT THE PATIENT EXPERIENCED MODERATE DISCOMFORT AND REDNESS WITH A WATERY DISCHARGE. THE PATIENT WAS DIAGNOSED WITH AN INFECTIOUS CORNEAL ULCER. THE ULCER WAS LOCATED MID PERIPHERY AND IS 1.0 MM IN SIZE. A 1.0 MM INFILTRATE ASSOCIATED WITH THE ULCER WAS ALSO NOTED. THE ECP INDICATED THAT PERMANENT SCARRING IS LIKELY, HOWEVER, NO PERMANENT SCARRING WAS NOTED. THERE WAS NO ANTERIOR CHAMBER REACTION. MILD CORNEAL STAINING WAS NOTED IN THE AREA OF THE ULCER. THE PATIENT WAS PRESCRIBED MOXIFLOXACIN OPHTHALMIC DROPS EVERY HOUR IN OD X 2 DAYS. THE PATIENT RETURNED FOR A FOLLOW UP APPOINTMENT ON (B)(6) 2015 AND THE MOXIFLOXACIN OPHTHALMIC DROPS WERE TAPERED TO FOUR TIMES DAILY. THE PATIENT WAS ALSO PRESCRIBED CIPROFLOXACIN DROPS AT ONE DROP NIGHTLY IN THE OD X 1 WEEK AND WAS INSTRUCTED TO DISCONTINUE CONTACT LENS WEAR. AT THE TIME OF THE REPORT COMPLETION FROM THE ECP, (B)(6) 2015, THE EVENT HAD NOT RESOLVED. ADDITIONAL INFORMATION FROM THE PATIENT RECEIVED ON (B)(6) 2015 THE PATIENT STATED THAT CONTACT LENS WEAR HAS RESUMED WITHOUT FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159278 DAILIES TOTAL 1 LENSES, SOFT CONTACT, DAILY WEAR LPL CIBA VISION GMBH NA N1117304

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other| R