BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS DAILIES TORIC (AQUA RELEASE)

    MDR report key: 5005101 · Received August 14, 2015

    Report

    Report Number
    9610813-2015-00528
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    February 1, 2015
    Report Date
    September 8, 2015
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K050065
    Removal / Correction Number
    NOT APPLICABLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    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.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE EYE CARE PROFESSIONAL ON (B)(6) 2015 THAT THE PATIENT DEVELOPED A VERY SIGNIFICANT LEFT EYE FUNGAL KERATITIS AND HAS BEEN UNDER AGGRESSIVE AND CONTINUAL TREATMENT. THE EVENT OCCURRED IN (B)(6) OF 2015. THE PATIENT DID NOT HAVE LENSES IN THE EYE WHEN THE EVENT OCCURRED, SHE HAD REMOVED THEM PRIOR TO GOING FOR A WALK AND FEELING SOMETHING GO INTO HER EYE. SHE REPORTS NO PRIOR EYE INJURY ESPECIALLY NO VEGETATIVE INJURY AND WEARS THE LENSES AS A DAILY LENS AND NEVER REUSES THEM. SHE REPORTS THAT THE LENSES WERE FINE AND AS SHE OFTEN DID REMOVED THE LENSES AFTER A DAY AT SCHOOL AS A TEACHER. SHE THEN WENT FOR A WALK AND THE EYE BECAME UNCOMFORTABLE. THE NEXT MORNING THE EYE WAS WORSE AND SHE ATTENDED HER GENERAL PRACTITIONER. SHE RECALLED HE REMOVED A "FOREIGN BODY" WITH A COTTON TIP AND GAVE HER ANTI-BIOTIC OINTMENT. THE EYE BECAME INCREASING SORE AND RED AND BLURRED AND THEN SHE WENT TO THE EYE CARE PROFESSIONAL. SHE WAS IMMEDIATELY REFERRED TO AN OPHTHALMOLOGIST AND AN EVENTUAL DIAGNOSIS OF FUNGAL KERATITIS WAS MADE, WHICH WAS IDENTIFIED BY A HOSPITAL SCRAPE (UNKNOWN DATE). SHE HAD A SIGNIFICANT CORNEAL SCAR AND SOME REDUCED BEST CORRECTED VISUAL ACUITY (BCVA). THE EYE CARE PROFESSIONAL FELT THAT A FOREIGN BODY WHICH HAD BLOWN INTO HER EYES AT THE TIME OF THE INCIDENT MAY ALSO HAVE BEEN THE CAUSE OF THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2015 FROM THE OPTOMETRIST WHO CONFIRMED THAT THE PATIENT SAID THAT SHE STARTED TO FEEL UNCOMFORTABLE DURING HER WALK, AFTER SHE HAD REMOVED HER CONTACT LENSES. HE SAID THAT THE PATIENT HAD NOT YET RECOVERED FROM THE FUNGAL KERATITIS AND WILL NOT BE ABLE TO WEAR CONTACTS AGAIN DUE TO SIGNIFICANT CORNEAL SCARRING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538797 FOCUS DAILIES TORIC (AQUA RELEASE) LENS, CONTACT, (DISPOSABLE) MVN CIBA VISION GMBH NA N0532312

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention