BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN MYOPIA PHAKIC INTRAOULAR LENS

    MDR report key: 4258836 · Received November 12, 2014

    Report

    Report Number
    8040449-2014-00003
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 2, 2014
    Manufacturer
    OPHTEC BV
    Product Code
    MTA
    PMA / PMN Number
    P030028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOURTEEN YEARS POSTOP PATIENT PRESENTED WITH DISLOCATED LENS AND CATARACT. THE CAUSE OF THE DISLOCATION CANNOT BE CONFIRMED AND THE LENS WAS INADVERTENTLY THROWN AWAY SO IT COULD NOT BE EXAMINED. SURGEON ACKNOWLEDGED THAT ORIGINAL SURGERY REQUIRED SIGNIFICANT MANIPULATION OF THE DEVICE THAT MAY HAVE CAUSED DAMAGE AND THAT THE AMOUNT OF TISSUE HOLDING THE DEVICE IN PLACE WAS NOT OPTIMAL. PATIENT WAS TREATED BY REMOVING THE LENS AND PERFORMING CATARACT SURGERY WITH IOL IMPLANTATION. REMOVAL AND CATARACT SURGERY WERE UNEVENTFUL. THE PATIENT'S CONTRALATERAL EYE ALSO RECEIVED THE SAME MODEL OF LENS AND HAS HAD NO PROBLEMS.

    Description of Event or Problem · 1

    PATIENT NOTICED CHANGED IN VISION. PRESENTED WITH DISLOCATED PHAKIC LENS AND POSTERIOR SUBCAPSULAR CATARACT. SURGEON REMOVED PHAKIC LENS, PERFORMED CATARACT SURGERY AND APHAKIC IOL IMPLANTATION. CAUSE OF DISLOCATION UNKNOWN. CAUSE OF CATARACT LIKELY RELATED TO HIGH MYOPIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729889 ARTISAN MYOPIA PHAKIC INTRAOULAR LENS PHAKIC INTRAOCULAR LENS MTA OPHTEC BV 204 56541

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention