BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHACOR; ALPHACOR-A, ALPHACOR-P ARTIFICAL CORNEA

    MDR report key: 473605 · Received July 9, 2003

    Report

    Report Number
    77002-2003-00001
    Event Type
    Malfunction
    Date Received
    July 9, 2003
    Date of Event
    June 13, 2003
    Report Date
    July 8, 2003
    Manufacturer
    ARGUS BIOMEDICAL PTY LTD, LIONS EYE INSTITUTE BLDG
    Product Code
    HQM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2003, ARGUS BIOMEDICAL WAS ADVISED BY A SURGEON VIA EMAIL THAT HIS PATIENT (IMPLANTED WITH THE ARGUS ALPHACOR KERATOPROSTHESIS IN 2001) HAD DEVELOPED A "SEMI-CIRCULAR BREAK IN THE KPRO OPTIC FROM 4.00 TO 11.00 O'CLOCK". THE PATIENT PRESENTED WITH ITCHING AND WATERING OF THE INVOLVED EYE. THE SURGEON WAS ADVISED THAT THE BEST COURSE OF ACTION WAS TO REPLACE THE DEVICE, PREFERABLY REINFORCING THE ANTERIOR SURFACE WITH DONOR TISSUE. THE SURGEON EXPLANTED THE DAMAGED KERATOPROSTHESIS AND PERFORMED REPLACEMENT SURGERY. THE SURGERY WAS REPORTED AS BEING UNEVENTFUL AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED TO DATE. THE PATIENT HAS HAD AN EXCELLENT OUTCOME FOLLOWING THE REPLACEMENT SURGERY AND FOLLOW UP CARE WILL CONTINUE TO BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHACOR; ALPHACOR-A, ALPHACOR-P ARTIFICAL CORNEA KERATOPROSTHESIS (ARTIFICIAL CORNEA) HQM ARGUS BIOMEDICAL PTY LTD, LIONS EYE INSTITUTE BLDG KPRO II 160200

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR TERRAMYCIN, 2002