BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 217855 · Received April 1, 1999

    Report

    Report Number
    2028159-1999-00093
    Event Type
    Malfunction
    Date Received
    April 1, 1999
    Date of Event
    March 2, 1999
    Report Date
    March 2, 1999
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR NOTED HIGH FLOW RATE CAUSED POSTERIOR CAPSULE TEAR DURING PROCEDURE. NO INTERVENTION REQUIRED AND IOL WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPTHALMIC SURGERY SYSTEM HQE ALCON LABORATORIES, INC. STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO