BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1844734 · Received September 23, 2010

    Report

    Report Number
    2028159-2010-01813
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ALCON -IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM REPORTED. A LASER PROBE WAS INSERTED AND FIRED WITH NO BURNING SMELL NOTED. THE LASER SUB-MODULE WAS DISASSEMBLED AND VISUALLY CHECKED WITH NO PROBLEMS FOUND. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L, RELATED REPORTS FOR THIS SYSTEM. (B)(4).

    Description of Event or Problem · 1

    THE NURSE REPORTED A BURNING SMELL WHEN USING THE LASER. THE CASE WAS COMPLETED AS PLANNED. NO PT INJURY WAS REPORTED.

    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