BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 2574129 · Received May 2, 2012

    Report

    Report Number
    3005675890-2012-00003
    Event Type
    Injury
    Date Received
    May 2, 2012
    Date of Event
    April 2, 2012
    Report Date
    May 2, 2012
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE INCIDENT INCLUDED SURGEON INTERVIEW AND SUBSEQUENT ANALYSIS OF THE CATARACT SURGERY VIDEO. FROM THIS ANALYSIS THE INCOMPLETE CAPSULOTOMY WAS CONFIRMED. HOWEVER, THE SURGEON SUPPOSITION THAT PIGMENT FROM THE SYNECHAIE/UVEITIS MAY HAVE CAUSED AND/OR CONTRIBUTED TO THE INCOMPLETE CAPSULOTOMY COULD NOT BE CONFIRMED. FROM THE VIDEO ANALYSIS, IT WAS DIFFICULT TO CONFIRM THE TIME COURSE OF THE REPORTED ANTERIOR CAPSULE TEAR. IT WAS NOTED THAT A RESIDUAL ATTACHMENT OF THE CAPSULOTOMY DISC WAS SEPARATED USING RADIAL TRACTION AS OPPOSED TO USING STANDARD CONTINUOUS CURVILINEAR CAPSULORRHEXIS (CCC) SURGICAL TECHNIQUE AND THAT THIS MAY HAVE CAUSED AND/OR CONTRIBUTED TO THE REPORTED ANTERIOR CAPSULE TEAR. THE CATALYS SYSTEM OPERATOR MANUAL CONTAINS A WARNING WHICH STATES: "STANDARD CONTINUOUS CURVILINEAR CAPSULORRHEXIS (CCC) SURGICAL TECHNIQUE MUST BE USED FOR SURGICAL REMOVAL OF THE CAPSULOTOMY DISC. THE CAPSULOTOMY MAY HAVE RESIDUAL UNCUT AREAS THAT SHOULD BE COMPLETED BY ADVANCING THE CAPSULE THROUGH THE INCOMPLETELY CUT AREA IN A CIRCUMFERENTIAL FASHION, RATHER THAT PULLING IT RADIALLY. THE USE OF IMPROPER CAPSULOTOMY DISC REMOVAL TECHNIQUE MAY POTENTIALLY CAUSE OR CONTRIBUTE TO ANTERIOR CAPSULE TEAR AND/OR A NONCIRCULAR, IRREGULARLY SHAPED CAPSULOTOMY." THE OCCURRENCE OF THE POSTERIOR TEAR/RUPTURE WAS CONFIRMED TO HAVE OCCURRED LATER IN THE PROCEDURE DURING ULTRASOUND PHACOEMULSIFICATION FOR LENS REMOVAL. AFTER THE POSTERIOR RUPTURE REMNANTS OF THE LENS WERE SUCCESSFULLY REMOVED WITHOUT POSTERIOR DISPLACEMENT OF THE NUCLEUS. THE CATARACT SURGERY WAS SUCCESSFULLY COMPLETED WITH THE IMPLANT OF A INTRAOCULAR LENS IN THE CILIARY SULCUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT (WHO PRESENTED WITH SYNECHAIE AND UVEITIS) UNDERWENT ANTERIOR CAPSULOTOMY AND LENS FRAGMENTATION WITH THE CATALYS SYSTEM EXPERIENCED A SUSPECTED INCOMPLETE CAPSULOTOMY AND ANTERIOR CAPSULE TEAR WHEN THE SURGEON REMOVED THE CAPSULOTOMY DISC. THE SURGEON CONJECTURED THAT THE PIGMENT FROM THE SYNECHAIE/UVEITIS MAY HAVE CONTRIBUTED TO THE INCOMPLETE CAPSULOTOMY. THE ANTERIOR CAPSULE TEAR SUBSEQUENTLY EXTENDED TO THE POSTERIOR CAPSULE, WITH POSTERIOR CAPSULE RUPTURE, DURING ASPIRATION AND PHACOEMULSIFICATION OF THE LENS. A NUCLEUS LOOP WAS USED TO SECURE THE LENS AND REMOVE THE HARD CORTICAL REMNANTS. AN ANTERIOR VITRECTOMY WAS PERFORMED AND AN INTRAOCULAR LENS IMPLANTED IN THE CILIARY SULCUS. POST-OPERATIVELY THE PT PRESENTED WITH SATISFACTORY VISUAL REHABILITATION AND WAS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention