BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS SYSTEM

    MDR report key: 5040477 · Received August 29, 2015

    Report

    Report Number
    3005675890-2015-00044
    Event Type
    Malfunction
    Date Received
    August 29, 2015
    Date of Event
    July 31, 2015
    Report Date
    September 29, 2015
    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
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI #:(B)(4). DATE OF EVENT USED OF (B)(6) 2015 IS A BEST ESTIMATE AS EXACT DATE IS UNKNOWN. (B)(6). 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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT EQUIPMENT WAS HAVING VACUUM ISSUES DURING LASER FIRING BUT DURING FOLLOW UP IT WAS FOUND THAT THE VACUUM ISSUES OCCURRED DURING DAILY VERIFICATION WHICH IS BEFORE PATIENT TREATMENT. THERE WAS NO PATIENT INVOLVED AND THEREFORE NO EQUIPMENT MALFUNCTION.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT EQUIPMENT IS HAVING VACUUM ISSUES DUE TO BALANCED SALT SOLUTION INGRESS INTO THE EQUIPMENT WHILE LASER IS FIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573729 CATALYS SYSTEM CATALYS OOE ABBOTT MEDICAL OPTICS CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1