BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 800CS

    MDR report key: 2855387 · Received November 28, 2012

    Report

    Report Number
    2028159-2012-01877
    Event Type
    Injury
    Date Received
    November 28, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND REPLACED THE CPU BATTERY AND SEAL FOR DIAGNOSTIC PURPOSES. THE SYSTEM WAS THEN TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. NO SAMPLES WERE RETURNED FOR EVAL. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO 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 ADD'L SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CLINICAL SUPERVISOR REPORTED THAT THE CASSETTES WERE NOT "SETTING RIGHT" DURING A PROCEDURE AND THAT THE VACUUM WOULD NOT STOP. THE STAFF KEPT HAVING TO EJECT THE CASSETTES. AN IRIS INJURY TO THE PT WAS NOTED. ADD'L INFO WAS REQUESTED. A COMPLETED QUESTIONNAIRE WAS RETURNED BY THE CLINICAL SUPERVISOR REPORTED THAT THE PHACO MACHINE FAILED TO DRAIN INTO THE CASSETTE WHICH "FROZE" THE MACHINE AND SUCTION WAS NOT RELEASED FROM THE PT'S IRIS. AN ANTERIOR VITRECTOMY WAS THEN REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention DUOVISC| ACCURUS ANTERIOR PAK W/O REFLUX