BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 398490 · Received June 6, 2002

    Report

    Report Number
    2028159-2002-00141
    Event Type
    Injury
    Date Received
    June 6, 2002
    Date of Event
    May 7, 2002
    Report Date
    May 7, 2002
    Manufacturer
    ALCON - IRVINE TECHNILOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED POSTERIOR CAPSULE TEAR OCCURRED DURING CAPSULE POLISHING, POSSIBLY DUE TO BURR ON INSIDE WALL OF I/A PORT IN TIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention