BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 3809748 · Received April 25, 2014

    Report

    Report Number
    3005675890-2014-00015
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 25, 2014
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 OPERATING ROOM SURGICAL VIDEO WERE NOT AVAILABLE FOR ANALYSIS. FROM THE ANALYSIS OF THE SYSTEM DATABASE AND THE SYSTEM OCT RECORDING THERE WERE NO SYSTEM RELATED ANOMALIES FOUND AND ALL SETTINGS AND PARAMETERS OF THE SYSTEM WERE FOUND TO BE WITHIN ACCEPTABLE LIMITS. THE SYSTEM DATABASE VIDEO IMAGES INDICATED THE ABSENCE OF, OR MINIMAL, EYE MOVEMENT DURING THE LASER TREATMENT. THE SURGEON REPORTED THAT THE TEAR WAS NOT RADIAL BUT AT AN OBLIQUE ANGLE, APPROXIMATELY 180 DEGREES FROM THE MAIN CORNEAL INCISION. IT IS UNKNOWN IF THE SURGEON USED THE STANDARD CONTINUOUS CURVILINEAR CAPSULORHEXIS (CCC) SURGICAL TECHNIQUE TO REMOVE THE CAPSULOTOMY DISC. THE CATALYS SYSTEM PERFORMED AS DESIGN; HOWEVER THE CAUSE(S) OF THE ANTERIOR CAPSULE TEAR IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ANTERIOR CAPSULOTOMY, LENS FRAGMENTATION, AND CORNEAL INCISIONS WITH THE CATALYS SYSTEM SUBSEQUENTLY EXPERIENCED AN ANTERIOR CAPSULE TEAR IN THE OPERATING ROOM (OR) DURING THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. THE SURGEON NOTED THE CAPSULE TEAR DURING IRRIGATION/ASPIRATION (I/A). NO MEDICAL INTERVENTION AND/OR ADDITIONAL COMPLICATION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251785 CATALYS PRECISION LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE OPTIMEDICA CORPORATION CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other