BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 4277802 · Received November 25, 2014

    Report

    Report Number
    3005675890-2014-00032
    Event Type
    Injury
    Date Received
    November 25, 2014
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2014
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING YEAR 2013. INVESTIGATION OF THIS INCIDENT INCLUDED VISUAL ANALYSIS OF THE SYSTEM DATABASE AND SYSTEM OPTICAL COHERENCE TOMOGRAPHY (OCT) RECORDINGS. FROM THE VISUAL ANALYSIS IT WAS DETERMINED THAT THERE NO SYSTEM ANOMALIES OBSERVED AND ALL SETTINGS AND PARAMETERS OF THE SYSTEM WERE FOUND TO BE WITHIN ACCEPTABLE LIMITS. THE SYSTEM DATABASE VIDEO IMAGES INDICATED MINIMAL EYE MOVEMENT DURING THE LASER TREATMENT. INFORMATION WAS REQUESTED TO THE SURGEON HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT. THE CAUSE OF THE POSTERIOR TEAR/RIP IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED EQUIPMENT HAD ERROR MESSAGE DISPLAY. TECHNICAL SUPPORT WAS CONTACTED AND SURGEON WAS ADVISED TO REBOOT THE LASER AND PERFORM A VERIFICATION ALIGNMENT AND A TEST SPHERE. AFTER THIS THE PATIENT WAS TREATED SUCCESSFULLY WITHOUT ANY ERRORS. AFTER THE LENS WAS REMOVED, SURGEON REPORTED THAT HE SAW A ''RIP'' IN THE POSTERIOR CAPSULE. THE REMAINING PROCEDURES OF THE DAY WERE COMPLETED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765921 CATALYS PRECISION LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE OPTIMEDICA CORPORATION CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other