BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 3893794 · Received June 12, 2014

    Report

    Report Number
    3005675890-2014-00022
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 12, 2014
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS INCIDENT INCLUDED ANALYSIS OF THE SYSTEM DATABASE, THE SYSTEM OPTICAL COHERENCE TOMOGRAPHY (OCT) RECORDING, AND THE OPERATING ROOM SURGICAL VIDEO. THE SYSTEM VIDEO DISPLAY RECORDING WAS NOT AVAILABLE FOR ANALYSIS. FROM THE ANALYSIS OF THE SYSTEM DATABASE AND THE SYSTEM OCT 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 INDICATED THE ABSENCE OF, OR MINIMAL, EYE MOVEMENT DURING THE LASER TREATMENT. THE SURGEON STATED THAT THE ANTERIOR CAPSULOTOMY WAS 100% COMPLETE AND THE CAPSULOTOMY DISC APPEARED TO BE FREE-FLOATING. PHACOEMULSIFICATION WAS UTILIZED IN THE REMOVAL OF THE CATARACT LENS. THE SURGEON OBSERVED THE ZONULE DIALYSIS DURING CORTEX REMOVAL. THE CATALYS SYSTEM PERFORMED AS DESIGN; HOWEVER, THE CAUSE(S) OF THE THREE CLOCK HOURS OF ZONULE DIALYSIS IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ANTERIOR CAPSULOTOMY AND LENS FRAGMENTATION WITH THE CATALYST SYSTEM (SYSTEM) SUBSEQUENTLY EXPERIENCED THREE CLOCK HOURS OF ZONULE DIALYSIS IN THE OPERATING ROOM (OR) DURING THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. THE SURGEON PERFORMED A VITRECTOMY AND INSERTED A CAPSULE TENSION RING. NO OTHER COMPLICATION AND/OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348673 CATALYS PRECISION LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE OPTIMEDICA CORPORATION CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other