BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 1341915 · Received March 11, 2009

    Report

    Report Number
    2028159-2009-00072
    Event Type
    Injury
    Date Received
    March 11, 2009
    Date of Event
    January 6, 2009
    Report Date
    February 10, 2009
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND REPLACED THE TRANSDUCER TUBING AND VENT STINGER FOR THE LOW VACUUM REPORTED. THE COMPANY SERVICE REP CLEANED THE DRAIN BASIN AND PLUNGERS. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. THE PARTS REPLACED WERE DISPOSED OF IN THE FIELD. A REVIEW OF COMPLAINTS FOR THIS SYSTEM FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL REPORTS FOR THIS SYSTEM. THE ROOT CAUSE OF THE LOW VACUUM HAS BEEN ATTRIBUTED TO A NONCONFORMING TRANSDUCER TUBING AND VENT STINGER. POSTERIOR CAPSULES TEAR IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. HOWEVER, A REVIEW OF THE COMPLAINT TRENDS SHOWS THAT THE FREQUENCY REPORTED IS WITHIN KNOWN LEVELS FOR THIS EVENT.

    Description of Event or Problem · 1

    THE NURSE REPORTED THE SURGEON NOTED IRRIGATION AND ASPIRATION ISSUES. ADDITIONAL INFORMATION RECEIVED STATED THE SURGEON HAD A POSTERIOR CAPSULE TEAR DUE TO LOW VACUUM. THE EVENT WAS NOT TRIGGERED BY ANY PARTICULAR ACTION AND NO SYSTEM MESSAGES DISPLAYED. THE CASE WAS COMPLETED AND AN IOL WAS IMPLANTED. THE NURSE STATED NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQE ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability