BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 5532843 · Received March 29, 2016

    Report

    Report Number
    3005675890-2016-00016
    Event Type
    Injury
    Date Received
    March 29, 2016
    Date of Event
    February 1, 2016
    Report Date
    April 13, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    OOE
    Removal / Correction Number
    Z-1515-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A REVIEW OF THE RECORDS RELATED TO THIS EQUIPMENT SHOWS NO FAILURE DETECTED. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. EQUIPMENT LABELING PROVIDES POTENTIAL ADVERSE EFFECTS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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. FIELD SERVICE SPECIALIST VISITED ACCOUNT AND REPLACED THE VACUUM REGULATOR. 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 WILL ISSUE 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

    ACCOUNT REPORTED THAT LOW PATIENT VACUUM WAS DETECTED BY THE SYSTEM WHEN THE LASER WAS FIRING. THE CUSTOMER IS NOT REALLY SURE IF THE SUCTION WAS COMPLETELY LOST DURING THE TREATMENT. THE EVENT OCCURRED AFTER FRAGMENTATION HAD STARTED AND DUE TO IT THE FRAGMENTATION WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187902 CATALYS SYSTEM CATALYS OOE ABBOTT MEDICAL OPTICS CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other