BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3843649 · Received March 25, 2014

    Report

    Report Number
    2028159-2014-00486
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Report Date
    February 24, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE SAMPLE WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED, THE ROOT CAUSE FOR THE BUBBLES CANNOT BE DETERMINED. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNK, SPECIFIC A ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON INDICATED THAT THEY ARE CONTINUING TO EXPRESS CONCERNS IN OBSERVING BUBBLES FROM THE VITRECTOMY PROBE LINE AS IT ASPIRATES BACK TO THE CASSETTE. HE FEELS THIS IS SLOWING HIS VITRECTOMY PROCEDURE AND CAUSING IT TO TAKE LONGER THAN NEEDED. THERE HAS NOT BEEN ANY PT INJURY; HOWEVER, HE IS CONCERNED THAT THIS ISSUE HAS NOT BEEN ADDRESSED OR CORRECTED. OUR ORIGINAL CONVERSATIONS EXPLAINED THE BUBBLE IN THE TUBING BEING CAUSED BY THE HIGH VACUUM BEING APPLIED TO SUCH A SMALL SURFACE AREA THAT IT WAS REMOVING THE AIR FROM THE FLUID AS SEEN IN THE TUBING. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173948 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1