BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES VISITINT AQUACOMFORT PLUS

    MDR report key: 3133375 · Received May 24, 2013

    Report

    Report Number
    1065835-2013-00002
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 11, 2013
    Manufacturer
    CIBA VISION CORPORATION
    Product Code
    MVN
    PMA / PMN Number
    K072777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. UNOPENED PRODUCT FROM THE SAME LOT WAS RETURNED AND FOUND TO BE WITHIN SPECIFICATION. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT A CORNEAL ULCER DEVELOPED AND REQUIRED FREQUENT MEDICAL ATTENTION. THE CORNEAL ULCER APPEARED TO BE BACTERIAL, REQUIRING ANTIBIOTIC USE EVERY HOUR IN ADDITION TO STEROID DROPS. THE CONDITION IS CURRENTLY ONGOING. IT IS NOTED THAT THE RELATIONSHIP OF THE ULCER TO CONTACT LENS IS PROBABLE, HOWEVER UNDETERMINED. RECEIVED ADDITIONAL INFORMATION FROM THE PATIENT ON (B)(6) 2013 WHICH STATES THAT SHE WAS DIAGNOSED WITH ULCERATIVE KERATITIS. SHE HAD AN APPOINTMENT WITH THE EYE CARE PROFESSIONAL (ECP) ON (B)(6) 2013, TWO APPOINTMENTS ON (B)(6) 2013, (B)(6) 2013 AND HAD A FOLLOW UP SCHEDULED FOR (B)(6) 2013. SHE WAS PRESCRIBED MOXIFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION (VIGAMOX), 1 DROP PER HOUR AS PRESCRIBED ON (B)(6) 2013, VIGAMOX AND BESIFLOXACIN OPHTHALMIC SUSPENSION, 0.6% (BESIVANCE) ALTERNATING 1 DROP EVERY HOUR AND LOTEPREDNOL ETABONATE GEL 0.5% (LOTEMAX) 2 TIMES A DAY AS PRESCRIBED ON (B)(6) 2013 AND VIGAMOX AND BESIVANCE 1 DROP ALTERNATING EVERY TWO HOURS AND LOTEMAX FOUR TIMES A DAY UNTIL FURTHER NOTICE. SHE STATED THAT SHE IS NOT EXPECTED TO RESUME LENS WEAR FOR ANOTHER COUPLE OF WEEKS. RECEIVED ADDITIONAL INFORMATION FROM THE TREATING ECP ON (B)(6) 2013 STATING THAT THEY WILL NOT DISCUSS ANYTHING REGARDING THIS PATIENT'S CONDITION DUE TO THE PATIENT NOT ALLOWING IT. THE PATIENT WILL NOT GIVE ANY ADDITIONAL INFORMATION REGARDING THE EVENT HOWEVER STATED THAT THE ULCER WAS NOT "DIRECTLY" RELATED TO CONTACT LENSES AND THAT THE ECP DID TELL HER THAT WEARING CONTACT LENSES DOES INCREASE THE RISK OF DEVELOPING ULCERS. THE PATIENT CONFIRMED THAT SHE IS DOING FINE NOW AND LENS WEAR HAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231608 DAILIES VISITINT AQUACOMFORT PLUS LENS, CONTACT (DISPOSABLE) MVN CIBA VISION CORPORATION A0317432

    Patients

    Seq Age Sex Outcome Treatment
    1 Other