BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3181642 · Received June 14, 2013

    Report

    Report Number
    2028159-2013-01161
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND THE PROBLEM REPORTED WAS NOT REPLACED. THE COMPANY REP MONITORED THE SYSTEM DURING A SURGERY BUT THE PROBLEM REPORTED WAS NOT OBSERVED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL 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 ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE EQUIPMENT LOCKED DURING A VITRECTOMY PROCEDURE. AN ALTERNATE SYSTEM WAS USED TOP COMPLETE THE CASE WITH NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271094 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR B NA

    Patients

    Seq Age Sex Outcome Treatment
    1