BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS SYSTEM

    MDR report key: 6074883 · Received November 2, 2016

    Report

    Report Number
    3005675890-2016-00075
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    September 30, 2016
    Report Date
    December 16, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K121091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AMO¿S INVESTIGATION SUBSEQUENTLY IDENTIFIED THAT THE CATALYS SYSTEM MAY HAVE A REMOTE POTENTIAL EVENT WHERE LOSS OF SUCTION DURING LASER FIRING COULD CREATE A HAZARDOUS SITUATION THAT MAY RESULT IN SCORING OF THE POSTERIOR CORNEAL SURFACE. THEREFORE AMO HAS ISSUED AN ADVISORY NOTICE TO REINFORCE INSTRUCTIONS PROVIDED IN PRODUCT TRAINING AND IN THE OPERATOR¿S MANUAL REGARDING SUCTION LOSS DURING A PROCEDURE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A REVIEW OF THE RECORDS RELATED TO THIS EQUIPMENT THAT INCLUDED LABELING, MANUAL, TRENDING, DEVICE HISTORY RECORDS AND RISK DOCUMENTATION REVIEWS FOR THIS EQUIPMENT WERE PERFORMED. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE CATALYS SYSTEM SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. EQUIPMENT LABELING PROVIDES POSSIBLE COMPLICATIONS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT SIGNIFICANT CHANGE OVER HISTORICAL COMPLAINT LIMITS AND NO RECOGNIZABLE ADVERSE TREND. BASED ON THE INVESTIGATION NO PROBLEM WAS FOUND. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT SYSTEM EXPERIENCED SUCTION LOSS WHILE LASER WAS FIRING. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THIS IS 4 OF 4 EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723916 CATALYS SYSTEM CATALYS OOE ABBOTT MEDICAL OPTICS CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 LIQUID OPTICS INTERFACE LOI-12 LOT 1376911