BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 515800 · Received March 11, 2004

    Report

    Report Number
    2028159-2004-00060
    Event Type
    Injury
    Date Received
    March 11, 2004
    Date of Event
    February 6, 2004
    Report Date
    February 10, 2004
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED POSTERIOR CAPSULE TEAR OCCURRED; REQUIRED ANTERIOR VITRECTOMY, FELT THERE WAS A VACUUM SURGE IN THE INSTRUMENT.

    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 NO INFO Required Intervention