BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS SYSTEM

    MDR report key: 5429443 · Received February 10, 2016

    Report

    Report Number
    3005675890-2016-00001
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    January 11, 2016
    Report Date
    February 10, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Removal / Correction Number
    Z-1515-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT; LASER CORRECTION SYSTEM, MODEL CATALYS-I, THAT HAS A SIMILAR PRODUCT, CATALYS-U WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER 510(K) # K121091. AMO'S INVESTIGATION SUBSEQUENTLY IDENTIFIED THAT THE CATALYST 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. IN ADDITION, AMO WILL BE MAKING ENHANCEMENTS FOR DETECTING AND ALERTING THE USER OF PATIENT SUCTION LOSS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    DURING A CATALYST PROCEDURE, THE SURGERY CENTER REPORTED LOSS OF SUCTION WHILE LASER FIRING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE IS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86778 CATALYS SYSTEM CATALYS OOE ABBOTT MEDICAL OPTICS CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1