BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES VISITINT AQUACOMFORT PLUS

    MDR report key: 3032194 · Received March 29, 2013

    Report

    Report Number
    1065835-2013-00004
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    November 22, 2012
    Manufacturer
    CIBA VISION CORPORATION
    Product Code
    LPL
    PMA / PMN Number
    K072777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT NAME WAS LENT SOFT. THIS IS A PRIVATE LABEL PRODUCT SIMILAR TO FOCUS DAILIES VISITINT (AQUA RELEASE). SINCE THE PRODUCT IS MANUFACTURED AT MULTIPLE LOCATIONS, IT IS UNKNOWN WHICH MANUFACTURING SITE WAS INVOLVED. A MANUFACTURING SITE WAS RANDOMLY SELECTED. THE REPORTED LOT NUMBER AS-70 IS NOT A VALID LOT NUMBER FOR THE COMPANY. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. SINCE THE SIMILAR PRODUCT IS MANUFACTURED AT MULTIPLE LOCATIONS, IT IS UNKNOWN WHICH MANUFACTURING SITE WAS INVOLVED. A MANUFACTURING SITE WAS RANDOMLY SELECTED. THREE MANUFACTURING SITES PERFORMED TREND RELATED INVESTIGATIONS. NO TRENDS COULD BE IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED BY A SPANISH HEALTH AUTHORITY THAT A PT'S FIRST ADMISSION TO THE HOSPITAL WAS ON (B)(6) 2012 WITH ACUTE KERATO-UVEITIS. THE TRANSLATION OF THE MEDICAL INFO PROVIDED INDICATES THAT ON (B)(6) 2012, THERE WAS A CORNEAL ABSCESS PRESENT. ON (B)(6) 2012, THE CORNEAL ABSCESS WAS WORSENING. ON (B)(6) 2012, A CULTURE OF THE CORNEAL SCRAPING REVEALED THE GROWTH OF FUSARIUM SP (ALSO, A BIOPSY AND CULTURE CONFIRMED THE SAME GROWTH ON (B)(6) 2102). INTRAVITREAL AMPHOTERICIN INJECTIONS WERE ADMINISTERED BETWEEN (B)(6) 2012. A DIAGNOSIS OF PURULENT ENDOPHTHALMITIS WAS MADE WITH EVISCERATION OF THE LEFT EYE PERFORMED. ADD'L INFO WAS RECEIVED ON (B)(6) 2013, WHICH STATES THAT THE DOCTOR PROVIDED MORE INFO REGARDING THE ISSUE. THE DOCTOR STATED THAT THE PT IS A WOMAN FROM (B)(6) WHO BOUGHT HER CONTACT LENSES ON THE INTERNET. SHE WENT TO AN OPTICIAN BECAUSE ONE OF THE CONTACT LENSES WAS YELLOW. WHEN SHE SHOWED THE LENS TO THE EYE CARE PROFESSIONAL (ECP), SHE WAS RECOMMENDED NOT TO USE THAT LENS AND OPEN ANOTHER ONE. WHEN THE PT CAME TO THE HOSPITAL REPORTING DISCOMFORT, SHE SAID THAT THE DISCOMFORT WAS DUE TO THE CONTACT LENS. HOWEVER, SHE WAS NOT WEARING THE LENS ON THE DAY SHE WENT TO THE HOSPITAL, THEREFORE, THE DOCTOR AT THE HOSPITAL NEVER SAW OR HAD THE CONTACT LENS THAT WA INVOLVED. ADD'L INFO HAS BEEN REQUESTED FROM THE DOCTOR, AS WELL AS THE HOSPITAL, BUT HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131027 DAILIES VISITINT AQUACOMFORT PLUS LENS, CONTACT (DISPOSABLE) LPL CIBA VISION CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other