BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 2860118 · Received December 1, 2012

    Report

    Report Number
    3005675890-2012-00010
    Event Type
    Injury
    Date Received
    December 1, 2012
    Date of Event
    November 2, 2012
    Report Date
    December 1, 2012
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE INCIDENT INCLUDED THE ANALYSIS OF THE SYSTEM DATABASE, SYSTEM OPTICAL COHERENCE TOMOGRAPHY (OCT) RECORDING, AND OR VIDEO OF THE SURGICAL PROCEDURE. FROM THE ANALYSIS, ALL SETTINGS AND PARAMETERS OF THE SYSTEM WERE FOUND TO BE WITHIN ACCEPTABLE LIMITS. THE CHAIR OF OPTIMEDICA'S MEDICAL ADVISORY BOARD PHYSICIAN ADVISOR REVIEWED THE SURGICAL OR VIDEO AND CONFIRMED THAT THE POSTERIOR LENS CAPSULE TEAR WAS CAUSED BY THE PHACOEMULSIFICATION TOOL. THE NOTED THAT THE PRIMARY CATARACT INCISION WAS LOCATED MORE CENTRALLY THAN NORMAL BY APPROXIMATELY 0.75MM. HE ALSO NOTED THAT THIS MORE VERTICAL APPROACH APPEARS TO HAVE BEEN DISTORTING THE CORNEA AND CONSEQUENTLY KINKING THE BSS INFUSION SLEEVE OF THE PHACOEMULSIFICATION TOO. THIS IN TURN MAY HAVE LEAD TO INADEQUATE INFUSION TO MAINTAIN THE ANTERIOR CHAMBER DEPTH WITH SUBSEQUENT INTERMITTENT SHALLOWING OF THE ANTERIOR CHAMBER, ALL OF WHICH MAY HAVE CONTRIBUTED TO THE PHACO TIP RUPTURING THE POSTERIOR LENS CAPSULE. THERE IS NO EVIDENCE THAT THE SYSTEM CUT THE POSTERIOR LENS CAPSULE NOR IS THERE ANY EVIDENCE OF A RADIAL TEAR IN THE ANTERIOR LENS CAPSULE.

    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 EXPERIENCED A POSTERIOR LENS CAPSULE TEAR AND DISPLACEMENT OF A PORTION OF THE LENS INTO THE VITREOUS DURING SURGICAL REMOVAL OF THE CATARACT IN THE OPERATING ROOM. THERE WAS NO NOTICEABLE EYE MOVEMENT DURING THE SYSTEM OCT SCAN AND/OR THE LASER TREATMENT. DURING THE CATARACT EXTRACTION, THE SURGEON REMARKED THAT THE MAIN PRIMARY CATARACT INCISION IN THE CORNEA WAS SOMEWHAT CENTRALLY LOCATED CAUSING THE PHACO TIP TO BE ANGLED DOWN INTO THE EYE MORE THAN THE SURGEON'S USUAL TECHNIQUE.

    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 63 YR Required Intervention