BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 3893912 · Received June 12, 2014

    Report

    Report Number
    9610813-2014-00012
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    February 8, 2014
    Report Date
    May 16, 2014
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K113168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVALUATION. 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 REPORTED BY THE EYE CARE PROFESSIONAL (ECP) THAT A PATIENT EXPERIENCED A PERIPHERAL CORNEAL ULCER WITH CORNEAL SCARRING WHILE WEARING THE DAILY DISPOSABLE CONTACT LENSES. THERE WAS NO VISION LOSS AND THE PATIENT'S SYMPTOMS HAVE RESOLVED. THE PATIENT WAS PRESCRIBED TOBRAMYCIN AND PREDNISOLONE. ADDITIONAL INFORMATION RECEIVED FROM THE ECP VIA MEDICAL RECORDS ON (B)(6) 2014 STATING THAT THE PATIENT VISITED THE ECP ON (B)(6) 2014 COMPLAINING THAT THE LEFT EYE HAD A WHITE DOT ON IT FOR 3 DAYS. PATIENT SAID THAT THE LEFT EYE STARTED HURTING THURSDAY MORNING ((B)(6) 2014) AND THE PATIENT HAS NOT WORN LENSES SINCE WEDNESDAY NIGHT ((B)(6) 2014). THE LEFT EYE IS IRRITATED AND FEELS LIKE THERE IS AN EYELASH, ALONG WITH LIGHT SENSITIVITY. THE EYE HAS RED BLOOD VESSELS ON THE OUTSIDE AND THERE HAS BEEN VERY MILD DRAINAGE THE LAST FEW DAYS. THE EYE HAS CLEARED UP AS OF RIGHT NOW. THE PATIENT WAS GIVEN TOBRAMYCIN OPHTHALMIC GTTS Q2-3 HRS. THE DIAGNOSIS AND PLAN STATED THAT THIS WAS A PERIPHERAL ULCER. DAILY LENS WEAR AND SUSPECT STAPH INFECTION IS LIKELY. THE PATIENT WAS WELL RESPONSIVE TO TOBRAMYCIN. SYMPTOMS HAVE RESOLVED. PATIENT WAS TO CONTINUE 4 TIMES PER DAY FOR A MINIMUM OF 8 TOTAL DAYS. THE PATIENT WAS ADDITIONAL GIVEN PCAL 1% SD OS TO USE 3 TIMES DAILY FOR ONE WEEK. THE PATIENT VISITED THE ECP AGAIN ON (B)(6) 2014 AND THE PATIENT HAD STOPPED TAKING PREDNISONE FOR A COUPLE OF DAYS AND THE PATIENT IS TO FINISH TOBRAMYCIN 3 TIMES ON SATURDAY AND 2 TIMES ON SUNDAY. THE WHITE DOT WAS VERY FAINT AT THIS POINT, WITH NO REDNESS, AND MILD IRRITATION AN ZERO DRAINAGE. IT WAS NOTED THAT THE PERIPHERAL ULCER, IS INACTIVE, THERE IS A SCAR, AND IT IS STILL EARLY, AND HAS GOOD SURFACE. PATIENT WAS OK TO DISCONTINUE TOBRAMYCIN AND CONTINUE PCAL 1% BID FOR 1 WEEK. PATIENT WAS CLEARED TO RESUME CONTACT LENS WEAR FOR 8 TO 10 HOURS IF THERE IS NO SENSATION, REDNESS, OR PAIN FOR 3 DAYS. THE PATIENT WAS INSTRUCTED TO RESUME LENS WEAR ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348894 DAILIES TOTAL 1 LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other