BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 3810066 · Received April 30, 2014

    Report

    Report Number
    3005675890-2014-00016
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 30, 2014
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS INCIDENT INCLUDED ANALYSIS OF THE SYSTEM DATABASE AND THE SYSTEM OPTICAL COHERENCE TOMOGRAPHY (OCT) RECORDING. THE SYSTEM VIDEO DISPLAY RECORDING AND THE OR SURGICAL VIDEO WERE NOT AVAILABLE FOR ANALYSIS. FROM THE ANALYSIS FO THE SYSTEM DATABASE AND THE SYSTEM OCT RECORDING HERE WERE NO SYSTEM RELATED ANOMALIES FOUND AND ALL OPERATING PARAMETERS OF THE SYSTEM WERE FOUND TO BE WITHIN ACCEPTABLE LIMITS. ANALYSIS OF THE SYSTEM OCT IMAGES SHOWED THAT HE LENS POSTERIOR SURFACE FIT WAS INCORRECT. THE SYSTEM DOES PROVIDE THE SURGEON WITH AN OPPORTUNITY TO MAKE A "FINAL REVIEW" OF THE SYSTEM SETTINGS PRIOR TO APPROVING THEM AND PROCEEDING WITH TREATMENT. THE SURGEON DID NOT MAKE ANY MANUAL ADJUSTMENTS TO CORRECT FOR THE IMPROPER FIT OF THE LENS POSTERIOR SURFACE BEFORE PROCEEDING WITH THE LASER TREATMENT. THE CATALYS SYSTEM OPERATOR MANUAL CONTAINS A WARNING WHICH STATES: "BEFORE INITIATING LASER TREATMENT, INSPECT THE IMAGES CREATED FROM THE OCT DATA, SURFACE FITS, AND OVERLAID PATTERN IN BOTH AXIAL AND SAGITTAL VIEWS, AND REVIEW THE TREATMENT PARAMETERS ON THE FINAL REVIEW SCREEN FOR ACCURACY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ANTERIOR CAPSULOTOMY AND LENS FRAGMENTATION WITH THE CATALYS SYSTEM (SYSTEM) SUBSEQUENTLY EXPERIENCED A POSTERIOR CAPSULE TEAR IN THE OPERATING ROOM (OR) DURING THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. A POSTERIOR VITRECTOMY WAS PERFORMED. NO ADDITIONAL MEDICAL INTERVENTION AND/OR COMPLICATIONS WERE REPORTED. THE SURGEON REPORTED AN EXCELLENT POST-OPERATIVE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258675 CATALYS PRECISION LASER SYSTEM OPTHALMIC FEMTOSECOND LASER OOE OPTIMEDICA CORPORATION CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other