BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES AQUACOMFORT PLUS TORIC

    MDR report key: 6967910 · Received October 23, 2017

    Report

    Report Number
    9610813-2017-00023
    Event Type
    Injury
    Date Received
    October 23, 2017
    Date of Event
    September 21, 2017
    Report Date
    December 11, 2017
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K123994
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION AND WAS FOUND TO MEET MANUFACTURING SPECIFICATIONS. THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE CONSUMER ON (B)(6) 2017 VIA TELEPHONE THAT HER EYE BECAME RED AND IRRITATION WAS FELT RIGHT AFTER WEARING THE CONTACT LENS ON (B)(6) 2017. THE CONSUMER VISITED A DOCTOR ON THE SAME DAY AND WAS DIAGNOSED WITH CORNEAL ULCER. THE CONSUMER WAS INSTRUCTED NOT TO WEAR CONTACT LENSES FOR A MONTH AND WAS PRESCRIBED WITH ANTIBIOTIC EYE DROPS. THE PRESCRIPTION WERE LEVOFLOXACIN EYE DROPS TO BE USED EIGHT TIMES A DAY, CEFMENOXIME HYDROCHLORIDE EYE DROPS TO BE USED FOUR TIMES A DAY, TOBRAMYCIN EYES DROPS TO BE USED EIGHT TIMES A DAY AND COLISTIMETHATE + ERYTHROMYCIN EYE DROPS TO BE USED FOUR TIMES A DAY. THE DURATION OF THE THERAPEUTIC REGIMEN WAS NOT SPECIFIED. ADDITIONAL INFORMATION WAS OBTAINED ON 10/06/2017. THE CONSUMER CONFIRMED THAT THE FIRST VISIT TO THE DOCTOR WAS MADE ON (B)(6) 2017 AND THIS WAS WHEN THE CORNEAL ULCER WAS CONFIRMED AT A TEN O'CLOCK LOCATION ON THE RIGHT EYE. IT WAS ALSO NOTED THAT THE AREA AROUND IT WAS RED. THE CONSUMER VISITED THE DOCTOR AGAIN ON (B)(6) 2017 AND THE CONSUMER WAS INSTRUCTED TO CONTINUE APPLYING THE PRESCRIBED EYE DROPS. THE SYMPTOM RESOLUTION AT THE TIME OF THIS REPORT IS CONFIRMED BY THE CONSUMER TO BE GETTING BETTER. ADDITIONAL INFO RECEIVED ON 10/20/2017 STATING THAT THE CONSUMER REVISITED THE DOCTOR ON (B)(6) 2017 AND WAS ADVISED TO HAVE A FOLLOW UP CHECK-UP IN ONE MONTH TIME. ADDITIONAL INFORMATION RECEIVED ON 11/15/2017 STATED THAT THE CONSUMER VISITED HER EYE CARE PROFESSIONAL ON (B)(6) 2017, WHO CONFIRMED THAT THE EVENT HAD RESOLVED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE CONSUMER ON (B)(6) 2017 VIA TELEPHONE THAT HER EYE BECAME RED AND IRRITATION WAS FELT RIGHT AFTER WEARING THE CONTACT LENS ON (B)(6) 2017. THE CONSUMER VISITED A DOCTOR ON THE SAME DAY AND WAS DIAGNOSED WITH CORNEAL ULCER. THE CONSUMER WAS INSTRUCTED NOT TO WEAR CONTACT LENSES FOR A MONTH AND WAS PRESCRIBED WITH ANTIBIOTIC EYE DROPS. THE PRESCRIPTION WERE LEVOFLOXACIN EYE DROPS TO BE USED EIGHT TIMES A DAY, CEFMENOXIME HYDROCHLORIDE EYE DROPS TO BE USED FOUR TIMES A DAY, TOBRAMYCIN EYES DROPS TO BE USED EIGHT TIMES A DAY AND COLISTIMETHATE + ERYTHROMYCIN EYE DROPS TO BE USED FOUR TIMES A DAY. THE DURATION OF THE THERAPEUTIC REGIMEN WAS NOT SPECIFIED. ADDITIONAL INFORMATION WAS OBTAINED ON (B)(6) 2017. THE CONSUMER CONFIRMED THAT THE FIRST VISIT TO THE DOCTOR WAS MADE ON (B)(6) 2017 AND THIS WAS WHEN THE CORNEAL ULCER WAS CONFIRMED AT A TEN O'CLOCK LOCATION ON THE RIGHT EYE. IT WAS ALSO NOTED THAT THE AREA AROUND IT WAS RED. THE CONSUMER VISITED THE DOCTOR AGAIN ON (B)(6) 2017 AND THE CONSUMER WAS INSTRUCTED TO CONTINUE APPLYING THE PRESCRIBED EYE DROPS. THE SYMPTOM RESOLUTION AT THE TIME OF THIS REPORT IS CONFIRMED BY THE CONSUMER TO BE GETTING BETTER. ADDITIONAL INFO RECEIVED ON (B)(6) 2017 STATING THAT THE CONSUMER REVISITED THE DOCTOR ON (B)(6) 2017 AND WAS ADVISED TO HAVE A FOLLOW UP CHECK-UP IN ONE MONTH TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750028 DAILIES AQUACOMFORT PLUS TORIC LENSES, SOFT CONTACT, DAILY WEAR MVN CIBA VISION GMBH NA N0645200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other