BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 2052573 · Received April 8, 2011

    Report

    Report Number
    2028159-2011-00348
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPRESENTATIVE EXAMINED THE SYSTEM AND COMPLETED A PREVENTIVE MAINTENANCE; NO SYSTEM PARTS ARE RETURNING FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED THAT DURING SURGERY, THE SYSTEM WOULD NOT ASPIRATE. THE HANDPIECE AND TIP WERE REPLACED, BUT THE SYSTEM STILL WOULD NOT ASPIRATE. THE SURGERY WAS CONVERTED TO EXTRACAPSULAR CATARACT EXTRACTION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SURGEON WAS IN PHACO MODE AND THE OCCLUSION BELL WAS HEARD. THE OPHTHALMOLOGIST REPORTED THAT THEY DO REUSE TIPS AND CASSETTES, WHICH ARE LABELED AS SINGLE USE DEVICES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention