BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2195226 · Received July 8, 2011

    Report

    Report Number
    2028159-2011-00797
    Event Type
    Other
    Date Received
    July 8, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM, CONFIRMED THE CUSTOMER'S REPORTED EVENT, AND REPLACED THE TOUCHSCREEN. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET SPECS. ADD'L PRODUCT INFO IS PENDING. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A HOSP BIOMED REPORTED THAT DURING SURGERY, THE TOUCHSCREEN WORKS INTERMITTENTLY. THE SURGERY WAS DISCONTINUED. NO HARM TO THE PT WAS REPORTED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other