BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI ELITE FRP (SOMOFILCON A)

    MDR report key: 7606757 · Received June 15, 2018

    Report

    Report Number
    9614392-2018-00017
    Event Type
    Injury
    Date Received
    June 15, 2018
    Report Date
    June 15, 2018
    Manufacturer
    COOPERVISION MANUFACTURING LTD
    Product Code
    LPL
    PMA / PMN Number
    K130342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS CANNOT BE PERFORMED. NO LENSES WERE RETURNED FOR EVALUATION AND LOT NUMBER IS UNKNOWN. THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE EVENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    MEDICAL INFORMATION RECEIVED FROM (B)(6), REGISTERED MEDICAL PRACTITIONER AND MEDICO-LEGAL WORKER. INFORMATION RECEIVED IS MR. (B)(6) INTERPRETATION OF INFORMATION FROM THE PATIENT (INTERVIEW AND POST-RESOLUTION EXAM) AND THE PATIENT'S MEDICAL RECORDS, MEDICAL RECORDS HAVE NOT BEEN RECEIVED BY THE MANUFACTURER FOR REVIEW. LIMITED MEDICAL INFORMATION IS AVAILABLE REGARDING THE ALLEGED INJURY. SAMPLES FOR CULTURE WERE TAKEN FROM THE PATIENT'S EYE, SOLUTION FROM AND WORN CONTACT LENS FROM USED STORAGE CASE. THE PRESENCE OF CANDIDA FUNGUS WAS CONFIRMED FROM THE SOLUTION IN THE LENS CASE. THE POSITIVE CULTURE WAS OBTAINED FROM A SOURCE WHICH HAVE BEEN EXPOSED TO ENVIRONMENTAL CONTAMINANTS. RESULTS OF CULTURES DIRECTLY FROM THE EYE WERE NOT DISCLOSED. UPON EXAM BY MR. (B)(6) IN (B)(6) 2018, ALL SIGNS WERE CLEAR AND BEST CORRECTED VISION WAS 6/5. WITH LIMITED INFORMATION REGARDING OCULAR INVOLVEMENT, THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO POSITIVE CULTURES OF CANDIDA FROM THE USED CONTACT LENS SOLUTION FROM THE CASE WHICH STORED THE LEFT CONTACT LENS AND ONLY LIMITED MEDICAL INFORMATION AVAILABLE. SHOULD FURTHER INFORMATION BECOME AVAILABLE, COOPERVISION WILL ALERT MHRA VIA A FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449844 CLARITI ELITE FRP (SOMOFILCON A) CLARITI ELITE FRP (SOMOFILCON A) LPL COOPERVISION MANUFACTURING LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other| R