BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2841975 · Received November 14, 2012

    Report

    Report Number
    2028159-2012-01706
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY
    Product Code
    HQC
    PMA / PMN Number
    K101285
    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 REP EXAMINED THE SYSTEM AND CONFIRMED THE SYSTEM MESSAGE (SM) [FUNCTION IS NOT ALLOWED WHEN THE FOOTSWITCH TREADLE IS DOWN OR BUTTONS ARE PRESSED]. REPORTED. THE FOOTSWITCH WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. 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 THE SYSTEM'S EVENT LOG REVEALED THAT SM "FUNCTION IS NOT ALLOWED WHEN THE FOOTSWITCH IS DOWN OR BUTTON ARE PRESSED" OCCURRED ON (B)(6) 2012 AT 11:58:43 AM, AND MULTIPLE TIMES AFTER THAT. 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 CUSTOMER REPORTED THAT DURING A PROCEDURE, A SYSTEM MESSAGE DISPLAYED AND THE SYSTEM LOCKED. THERE WAS NO PT HARM. HOWEVER, THE CASE WAS ABORTED AND RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention