BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTISAN MYOPIA LENS

    MDR report key: 3653288 · Received January 23, 2014

    Report

    Report Number
    8040449-2014-00001
    Event Type
    Other
    Date Received
    January 23, 2014
    Date of Event
    October 30, 2013
    Report Date
    January 22, 2014
    Manufacturer
    OPHTEC BV
    Product Code
    MTA
    PMA / PMN Number
    P030028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED BY OPERATING ROOM STAFF. DEVICE NOT AVAILABLE FOR EVALUATION. DEVICE DEFECT NOT SUSPECTED. NO OTHER REPORTS OF PROBLEMS WITH DEVICES IN THE SAME MFR LOT. DEVICE WAS REMOVED AS A PRECAUTIONARY MEASURE AND TO PERFORM CATARACT SURGERY REMOVAL WITH INTRAOCULAR LENS IMPLANTATION. REF. #: (B)(4). CAUSE OF REDUCED CORNEAL ENDOTHELIUM IS INCONCLUSIVE. LENS REMOVAL WAS PRECAUTIONARY.

    Description of Event or Problem · 1

    LATE REPORTING BY HEALTHCARE PROFESSIONAL. PT EXPERIENCED REDUCED CORNEAL ENDOTHELIAL CELL COUNTS 7 YEARS POSTOPERATIVE. THE SURGEON REMOVED THE PHAKIC INTRAOCULAR LENS AS A PRECAUTIONARY MEASURE AND CONDUCTED STANDARD CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. PT WAS IMPLANTED WITH PHAKIC INTRAOCULAR LENS IN 2006. IN 2013, DOCTOR NOTICED REDUCED CORNEAL ENDOTHELIUM DENSITY AND DEVELOPMENT OF CATARACT. PHAKIC LENS WAS REMOVED AS A PRECAUTION AND CATARACT REMOVAL WITH INTRAOCULAR LENS WAS PERFORMED. NO OTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54519 ARTISAN MYOPIA LENS PHAKIC INTRAOCULAR LENS MTA OPHTEC BV 206001W 79346

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CATARACT REMOVAL| CATARACT REMOVAL WITH INTRAOCULAR LENS| INTRAOCULAR LENS IMPLANTATION| IMPLANTATION