BEUDAMED
    FDA Adverse Event Other Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 2111167 · Received May 26, 2011

    Report

    Report Number
    2028159-2011-00586
    Event Type
    Other
    Date Received
    May 26, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 25, 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
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND RECONNECTED THE CABLES AND RESEATED THE PRINTED CIRCUIT BOARDS. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO SAMPLES WERE 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 NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A NURSING ASSISTANT REPORTED THAT AFTER THE EYE INCISION HAD BEEN PERFORMED, A SYSTEM MESSAGE WAS DISPLAYED. THE DOCTOR HAD TO RESORT TO AN EXTRACAPSULAR CATARACT EXTRACTION (ECCE) IN ORDER TO COMPLETE THE PROCEDURE BECAUSE THE CUSTOMER DID NOT OWN A SECOND SYSTEM. SUBSEQUENTLY, THE TWO FOLLOWING CASES WERE CANCELED. THERE WAS NO PATIENT HARM REPORTED. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE ADDITIONAL INFORMATION, BUT NONE HAS BEEN RECEIVED.

    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 Other