BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 1-DAY TRUEYE NARAFILCON A

    MDR report key: 3201483 · Received June 28, 2013

    Report

    Report Number
    1033553-2013-00058
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    September 1, 2012
    Report Date
    June 28, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPM
    PMA / PMN Number
    K073485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. SERIOUS REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS. NO EVALUATION WILL BE PERFORMED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(6) 2013 OUR AUTHORIZED REPRESENTATIVE CONTACT IN THE (B)(6) RECEIVED A YELLOW CARD VOLUNTARY REPORT FORM SUBMITTED BY AN OPTICIAN. THE FORM STATED "LOSS OF SIGHT RIGHT EYE, CHANCE OF LOSS OF SIGHT LEFT EYE." I SPOKE WITH THE OPTICIAN WHO REPORTED THAT THE PATIENT WAS INITIALLY SEEN BY A GENERAL PRACTITIONER AND TREATED FOR CONJUNCTIVITIS WITH CHLORAMPHENICOL. WHEN THE SYMPTOMS WORSENED, THE PATIENT WAS REFERRED TO AN OPHTHALMOLOGIST WHO DIAGNOSED FUSARIUM KERATITIS AND ADMITTED THE PATIENT TO THE HOSPITAL. A FORMAL REQUEST FOR RECORDS WAS SUBMITTED TO THE HOSPITAL BY FAX BUT ACCESS WAS DENIED DUE TO PRIVACY ACT CONCERNS. INFORMATION PROVIDED TO THE OPTICIAN BY A THIRD PARTY INFORMS THAT THE PATIENT HAS LOST VISION IN THE RIGHT EYE AND "THE CORNEA HAS BEEN REMOVED." WE ARE UNABLE TO CONFIRM THIS INFORMATION. THE OPTICIAN ALSO REPORTED A SECOND SIMILAR EVENT, WHICH WILL BE REPORTED SEPARATELY. EFFORTS TO CONTACT THE PATIENT ARE CONTINUING. PRODUCT HAS NOT BEEN MADE AVAILABLE FOR RETURN AND NO LOT INFORMATION WAS PROVIDED. A FORMAL REQUEST FOR RECORDS WAS SUBMITTED TO THE HOSPITAL BY FAX BUT ACCESS WAS DENIED DUE TO PRIVACY ACT CONCERNS. WE ARE UNABLE TO CONFIRM THIS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296299 ACUVUE 1-DAY TRUEYE NARAFILCON A SOFT CONTACT LENS LPM VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| S