BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 644737 · Received November 3, 2005

    Report

    Report Number
    2028159-2005-00193
    Event Type
    Injury
    Date Received
    November 3, 2005
    Date of Event
    October 4, 2005
    Report Date
    October 4, 2005
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CTR.
    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 POSTERIOR CAPSULE TEAR AT BEGINNING OF I/A. VITREOUS CAME FORWARD INTO ANTERIOR CHAMBER AND TO WOUND. NO FURTHER I/A PERFORMED. VITREOUS WAS CONTAINED, WOUND WIDENED, AND AC IOL IMPLANTED. AIR BUBBLE USED TO TAMPONADE VITREOUS. SUTURED WOUND TO CLOSE. PT REPORTED AS DOING FINE. DOCTOR BELIEVES THERE IS A ROUGH EDGE IN THE OPENING OF I/A TIP ASPIRATION PORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention