BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES AQUACOMFORT PLUS

    MDR report key: 3801671 · Received April 28, 2014

    Report

    Report Number
    1065835-2014-00005
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 18, 2014
    Manufacturer
    CIBA VISION CORPORATION
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THERE WERE NO NON-CONFORMITIES OR DEVIATION 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 AN EYE CARE PROFESSIONAL (ECP) THAT A PATIENT EXPERIENCED THAT LENSES WERE FOUND "TORN AT THE OPENING" AND CAUSED DISCOMFORT WITH A "GLUED SENSATION" IN THE EYES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014 FROM THE ECP STATING THAT THE CONTACT LENSES WERE TORN AND THE PATIENT HAD A SMALL ULCER IN HER RIGHT EYE. THE PATIENT EXPERIENCED PAIN AND THERE WERE NO INFILTRATES AND NO PERMANENT SCARRING NOTED. THE PATIENT SOUGHT MEDICAL ATTENTION AND FOLLOW UP CARE WITH HER OPHTHALMOLOGIST. ADDITIONAL INFORMATION RECEIVED FROM THE ECP OFFICE ON (B)(6) 2014 STATING THAT THE PATIENT VISITED THE ECP ON (B)(6) 2014, AND WAS GIVEN "ZALERG (KETOTIFEN)" AND TWO OTHER EYE DROPS (UNKNOWN). A FOLLOW UP APPOINTMENT WAS SCHEDULED ON (B)(6) 2014, AND THE ECP PRESCRIBED A DIFFERENT BRAND OF DAILY HYDROGEL SILICON LENSES AS WELL AS VITADROP (SODIUM HYALURONATE AND VITAMIN B12) EYE DROPS. THE EVENT HAS RESOLVED. LENS WEAR HAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253502 DAILIES AQUACOMFORT PLUS LENS, CONTACT (DISPOSABLE) LPL CIBA VISION CORPORATION A0368394

    Patients

    Seq Age Sex Outcome Treatment
    1 Other