BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 3231556 · Received July 15, 2013

    Report

    Report Number
    2028159-2013-01353
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 17, 2013
    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 COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE PROBLEM REPORTED. THE TRANSDUCER PRINTED CIRCUIT BOARD (PCB) WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED 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 24 MONTHS DID INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A SYSTEM MESSAGE WAS DISPLAYED INDICATING "FLUIDICS" AND THAT THE SYSTEM LOCKED DURING A CATARACT EXTRACTION PROCEDURE. FOLLOWING A DELAY OF MORE THAN 15 MINUTES, THE PROCEDURE WAS COMPLETED WITH A MANUAL TECHNIQUE (EXTRACAPSULAR CATARACT EXTRACTION). THERE WAS NO REPORTED HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325780 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other