BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 3893776 · Received June 12, 2014

    Report

    Report Number
    3005675890-2014-00021
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 15, 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
    MI, 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 OCT RECORDING IT WAS DETERMINED THAT 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 AND THE SYSTEM DATABASE CONFIRMED THAT A LOSS OF SUCTION DID OCCUR DURING THE FRAGMENTATION PORTION OF THE LASER TREATMENT. ACCORDING TO THE SURGEON, THE ANTERIOR CAPSULOTOMY WAS 100% COMPLETE AND STANDARD CONTINUOUS CURVILINEAR CAPSULORHEXIS (CCC) SURGICAL TECHNIQUE WAS USED TO REMOVE THE CAPSULOTOMY DISC. THE SLIVER WAS NOT NOTICED UNTIL AFTER SEPARATED WITH FORCEPS. 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 CATALYST SYSTEM (SYSTEM) SUBSEQUENTLY EXPERIENCED AN ANTERIOR CAPSULE TEAR IN THE OPERATING ROOM (OR) DURING THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. THE SURGEON OBSERVED THE CAPSULE TEAR DURING THE REMOVAL OF THE CAPSULOTOMY DISC. NO ADD'L COMPLICATION AND/OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348668 CATALYS PRECISION LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE OPTIMEDICA CORPORATION CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other