BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3963708 · Received May 7, 2014

    Report

    Report Number
    2028159-2014-00829
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. A SAMPLE HAS BEEN RECEIVED AND IN-HOUSE TESTING IN PROGRESS. THE DEVICE HISTORY RECORDS (DHR) FOR THE LOTS WERE REVIEWED. AN ACTUATION ISSUE WAS FOUND ON ONE OF THE TWO COMPONENT LOTS, HOWEVER, THE SUSPECTED PRODUCT WAS RE-INSPECTED AND THE PRODUCT WAS RELEASED ACCORDING TO THE MFR'S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY REVIEW INDICATES ZERO ADD'L COMPLAINTS WERE ASSOCIATED WITH THE ONE ACTUATION ISSUE COMPONENT LOTS. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A SCRUB TECH REPORTED THAT THE PROBE WOULD NOT CUT AT HIGH SPEED, ONLY AT THE LOWER SPEED DURING VITRECTOMY PROCEDURE. SHE FURTHER CLARIFIED THAT WHEN THE SURGEON WAS IN THE PT'S EYE AND ATTEMPTED TO INCREASE CUTTER SPEED, THE CUTTER STOPPED OPENING AND CLOSING. THE SCRUB TECH COULD NOT RECALL IF ASPIRATION WAS STILL WORKING OR NOT. THE PROBE WAS REPLACED TO CONTINUE THE CASE. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274311 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR CUSTOM PAK| TOTAL PLUS PAK 25+, 5000 CUTS PER MINUTE STD