BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 3760993 · Received April 9, 2014

    Report

    Report Number
    3005675890-2014-00012
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 10, 2014
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 OPERATING ROOM SURGICAL VIDEO WERE NOT AVAILABLE FOR ANALYSIS. FROM THE ANALYSIS OF THE SYSTEM DATABASE AND THE SYSTEM (B)(4) RECORDING THERE WERE NO SYSTEM RELATED ANOMALIES OBSERVED AND ALL SETTINGS AND PARAMETERS OF THE SYSTEM WERE FOUND TO BE WITHIN ACCEPTABLE LIMITS. THE SYSTEM DATABASE VIDEO IMAGES DID REVEAL THAT SIGNIFICANT VERTICAL EYE MOVEMENT OCCURED AFTER COMPLETION OF INITIAL OCT SCAN AND THE FITTING OF THE ARCUATE INCISION. THE SURGEON DID NOT RE-SCAN THE EYE AFTER THE EYE MOVEMENT OCCURRED AND PRIOR TO PROCEEDING FORWARD WITH THE LASER TREATMENT. THE CATALYST SYSTEM OPERATOR MANUAL CONTAINS A WARNING WHICH STATES: "CONTINUOUSLY VERIFY THAT THE EYE HAS NOT MOVED WITH RESPECT TO ITS INITIAL PRESENTATION AT THE TIME OF FLUID CONFIRMATION. IF THE EYE MOVES DURING INTEGRAL GUIDANCE, THEN PRESS "RESCAN EYE". IF THE EYE MOVES DURING LASER TREATMENT, THEN TERMINATE THE LASER TREATMENT BY IMMEDIATELY RELEASING THE LASER FOOTSWITCH."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ANTERIOR CAPSULOTOMY, LENS FRAGMENTATION, AND CORNEAL INCISIONS WITH THE CATALYST SYSTEM (SYSTEM) SUBSEQUENTLY EXPERIENCED AN ARCUATE INCISION THAT FULLY PERFORATED THE CORNEA IN THE OPERATING ROOM (OR) DURING THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. NO ADD'L COMPLICATION OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213313 CATALYS PRECISION LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE OPTIMEDICA CORPORATION CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other