BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 336542 · Received June 5, 2001

    Report

    Report Number
    2028159-2001-00173
    Event Type
    Injury
    Date Received
    June 5, 2001
    Date of Event
    May 10, 2001
    Report Date
    May 10, 2001
    Manufacturer
    ALCON- IRVIVE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED LOW VACUUMM AT BEGINNING OF I/A. POSTERIOR CAPSULE TEAR OCCURRED; ANTERIOR VITRECTOMY PERFORMED. SURGEON FELT HANDPIECE WAS OCCLUDED (ALARM SOUNDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25817 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON- IRVIVE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention