BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 2932237 · Received January 25, 2013

    Report

    Report Number
    2028159-2013-00027
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 27, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND DUPLICATED THE PROBLEM REPORTED. THE POWER SUPPLY WAS REPLACED. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID INDICATE ONE SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE CAN BE ATTRIBUTED TO NON-CONFORMING POWER SUPPLY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A CATARACT EXTRACTION PROCEDURE, A SYSTEM MESSAGE WAS DISPLAYED THAT COULD NOT BE CLEARED. A SECOND SYSTEM WAS BROUGHT IN TO COMPLETE THE PROCEDURE, BUT ALSO DISPLAYED A SYSTEM MESSAGE. THE CASE WAS ABORTED AND 30 SUBSEQUENT SURGERIES WERE CANCELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35905 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INFINITI VISION SYSTEM