BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 1153237 · Received September 5, 2008

    Report

    Report Number
    2028159-2008-00326
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE REVIEWED THE EVENT WITH THE CUSTOMER BY PHONE. BASED UPON A REVIEW OF THE REPORT, THE COMPANY SERVICE REPRESENTATIVE REPORTED THE HOSPITAL STATED THE NON-CONFORMITY WAS RELATED TO THE AIR LINE OF THE SYSTEM, AND THE "AIR LINE" WAS CONNECTED TO THE EYE IN ERROR". A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL REPORTS FOR THIS SYSTEM. THE CUSTOMER STATED THEY CONSIDER THAT NEITHER THE ANTERIOR VITRECTOMY PROBE NOR THE SYSTEM WERE DIRECTLY RESPONSIBLE FOR THIS REPORTED EVENT. THE NON-CONFORMITY WAS DUE TO THE FACT THE SURGEON MANAGED TO ATTACH THE IRRIGATING CONNECTOR FROM THE CLEAR TUBING ON THE I/A HANDPIECE INTO THE AIR LINE FOR THE VITRECTOMY PROBE ON THE SYSTEM. NO SAMPLES WERE RETURNED FOR INVESTIGATION. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE CUSTOMER REPORTED ISSUE AND THE ROOT CAUSE IS THEREFORE UNKNOWN AT THIS TIME. PROVIDED BY MANUFACTURER. THIS REPORT WAS MAILED TO FDA ON: 09/05/2008.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE SURGEON WAS PERFORMING ROUTINE PHACO A POSTERIOR CAPSULE TEAR OCCURRED. THE PATIENT WAS UNDER LOCAL ANESTHETIC AND DID NOT EXHIBIT INCREASED INTRAOCULAR PRESSURE WHEN THE POSTERIOR CAPSULAR BAG RUPTURED AND VITREOUS CAME FORWARD INTO THE ANTERIOR CHAMBER. THE SURGEON USED AN ANTERIOR VITRECTOMY PROBE TO PERFORM THE ANTERIOR VITRECTOMY. THE SURGEON THEN CHANGED TO THE IRRIGATION / ASPIRATION (I/A) HANDPIECE. THE SURGEON THEN WENT FROM THE I/A HANDPIECE TO THE VITRECTOMY PROBE. THEY INADVERTENTLY CONNECTED THE CLEAR PLASTIC TUBING FROM THE LEGACY CONSOLE TO THE IRRIGATION IN-FLOW PORT OF THE LEGACY. THE INCORRECT TUBING CONNECTION RESULTED IN AIR BEING PUSHED INTO THE EYE, RATHER THAN IRRIGATION. THE UNEXPECTED AIR PUSHED RESIDUAL CORTICAL MATTER INTO THE VITREOUS. THE SURGEON EXAMINED THE PATIENT ONE DAY POSTOP. THE PATIENT PRESENTED A VISUAL ACUITY OF 6/12, WITH THE EYE QUIET. THERE WAS NO SIGN OF INFECTION AND RETINA WAS FLAT.

    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 91 YR Required Intervention