BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 600DS

    MDR report key: 287329 · Received July 26, 2000

    Report

    Report Number
    2028159-2000-00175
    Event Type
    Malfunction
    Date Received
    July 26, 2000
    Report Date
    June 26, 2000
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED MILD CORNEAL BURN DURING PROCEDURE. NO INTERVENTION REPORTED; PT WILL RECOVER WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 600DS OPHTHALMIC SURGERY SYSTEM HQE ALCON - IRVINE TECHNOLOGY CENTER ACCURUS 600DS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO