BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 522336 · Received February 6, 2004

    Report

    Report Number
    2028159-2004-00031
    Event Type
    Malfunction
    Date Received
    February 6, 2004
    Date of Event
    January 7, 2004
    Report Date
    January 7, 2004
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED CORNEAL BURN OCCURRED DURING PROCEDURE. SUTURED WOUND FOR WATER TIGHT CLOSURE, RESULTING IN TEMPORARY INDUCED ASTIGMATISM. PROGNOSIS REPORTED AS GOOD. SURGEON FELT THIS WAS UNLIKELY TO CAUSE PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR