BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHACOR

    MDR report key: 535463 · Received June 25, 2004

    Report

    Report Number
    MW1032447
    Event Type
    Injury
    Date Received
    June 25, 2004
    Date of Event
    June 12, 2004
    Report Date
    June 24, 2004
    Manufacturer
    ARGUS BIOMEDICAL PTY LTD.
    Product Code
    HQM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PT HAD RECEIVED A CORNEAL PROSTHESIS. PT COMPLAINED OF DISCOMFORT: EXAMINATION REVEALED PROSTHESIS DISPLACED, WITH SOME INFECTION. PROSTHESIS WAS REMOVED AND A TISSUE GRAFT WAS MADE. PRIOR TO EVENT (CAUSE UNK) PT HAD 20/200 VISION IN THE RIGHT EYE; SUBSEQUENT TO REMOVAL AND GRAFT, PT HAS NO VISION IN THAT EYE. PT WAS TAKEN TO SURGERY AND THE PROSTHESIS AND UNDERLYING CORNEA TREPHINED OUT EN BLOCK, REVEALING AN ENDOPHTHALMITIS WHICH WAS NOT ACUTE AND MUST HAVE BEEN PRESENT FOR SEVERAL DAYS. PUT IN ANTIBIOTICS AND PLACED A GRAFT, BUT OF COURSE THERE IS NO VISION. DR CAN ONLY SURMISE THAT PT RUBBED THE SURFACE, EXTRUDING THE PROSTHESIS THROUGH THE ANTERIOR OPENING, AND INFECTION ENSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHACOR CORNEAL PROSTHESIS HQM ARGUS BIOMEDICAL PTY LTD. P *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention