BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE NARAFILCON A

    MDR report key: 2000983 · Received February 18, 2011

    Report

    Report Number
    1033553-2011-00012
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    October 29, 2010
    Report Date
    February 18, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K073485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM OUR (B)(4) AFFILIATE. ON (B)(6) 2011, THE PARENT OF A PATIENT REPORTED HIS/HER CHILD EXPERIENCED A MEDICAL ADVERSE EVENT WHILE WEARING 1-DAY TRUEYE NARAFILCON A CONTACT LENSES (NARAFILCON A PRODUCT IS NOT MARKETED IN THE U.S.). THE PATIENT EXPERIENCED PAIN OU AND PRESENTED TO THE (B)(6). ON (B)(6) 2011, AN OFFICE CLERK AT THE (B)(6) CONFIRMED THAT THE PATIENT WAS EXAMINED ON (B)(6) 2010, DIAGNOSED WITH IRIDOCYCLITIS AND KERATITIS IN THE RIGHT EYE (OD). THE PATIENT WAS PRESCRIBED CRAVIT AND ORGADRONE EYE DROPS. THE PATIENT DID NOT RETURN TO THE CLINIC FOR ADDITIONAL FOLLOW UP AS INSTRUCTED; THE DOCTOR COULD NOT CONFIRM THAT THE PATIENT'S OD RECOVERED. THE DOCTOR PRESUMED "THAT THIS EVENT WAS SEVERE FOR THE REASON THAT THE SYMPTOMS DEVELOPED IN EYE, BUT THE SYMPTOMS DID NOT RESULT IN INPATIENT TREATMENT OR LOSS OF VISION." THE AFFILIATE ALSO NOTED, "IN THE MEDICAL REVIEW, IT WAS CONFIRMED THAT THIS EVENT WAS NOT RELATED TO 1-DAY TRUEYE LENSES." THIS EVENT IS BEING REPORTED WORST CASE. THE LOT NUMBER OF THE PRODUCT IN QUESTION IS UNKNOWN AND THE PRODUCT IN QUESTION IS NOT AVAILABLE FOR RETURN FOR EVALUATION. NO ADDITIONAL INFORMATION IS EXPECTED TO BE RECEIVED REGARDING THIS EVENT. BASED ON THE LIMITED INFORMATION AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THIS TIME. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1-DAY ACUVUE TRUEYE NARAFILCON A SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other