BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS SYSTEM

    MDR report key: 298732 · Received September 29, 2000

    Report

    Report Number
    2028159-2000-00254
    Event Type
    Malfunction
    Date Received
    September 29, 2000
    Date of Event
    August 31, 2000
    Report Date
    August 31, 2000
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING INTERNAL INSPECTION, REPORTER NOTED "DO NOT REUSE" LABEL WAS MISSING ON ANTERIOR MULTI PACK PROCEDURE POUCH (TUBING SET).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS SYSTEM OPHTHALMIC SURGERY SYSTEM HQE ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA