BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 3217077 · Received July 3, 2013

    Report

    Report Number
    3005675890-2013-00014
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 5, 2013
    Report Date
    July 3, 2013
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE ANTERIOR TEARS WAS ATTEMPTED BUT DESPITE MULTIPLE REQUESTS, ADD'L INFO WAS NOT PROVIDED BY THE SURGEON. EVEN THOUGH THE SUBJECT PTS COULD NOT BE UNIQUELY IDENTIFIED, AN ANALYSIS OF THE SYSTEM DATABASE AND SYSTEM OPTICAL COHERENCE TOMOGRAPHY (OCT) RECORDINGS FOR ALL PTS TREATED ON THE INCIDENT DATE REVEALED THERE WERE NO ANOMALIES; AND ALL SETTINGS AND PARAMETERS OF THE SYSTEM WERE FOUND TO BE WITHIN ACCEPTABLE LIMITS. ADDITIONALLY, IT IS UNK IF THE SURGEON USED THE STANDARD TECHNIQUE TO REMOVE THE CAPSULOTOMY DISC. THE SPECIFIC QUANTITY AND CAUSE(S) OF THE ANTERIOR LENS CAPSULE TEARS ARE UNK. 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 THAN 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."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL PTS WHO UNDERWENT ANTERIOR CAPSULOTOMY WITH THE CATALYS SYSTEM (SYSTEM) SUBSEQUENTLY EXPERIENCED A RADIAL TEAR IN THE ANTERIOR CAPSULE. THE TEARS WERE OBSERVED TO BE IN THE INFERIOR RIGHT QUADRANT, WITH SOME TO THE LEFT. THE SURGEON REPORTED HAVING SEVEN OR EIGHT INCOMPLETE CAPSULOTOMIES BUT IT WAS UNCLEAR AS TO THE QUANTITY OF ACTUAL ANTERIOR CAPSULE TEARS. NO OTHER COMPLICATIONS AND/OR MEDICAL INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305905 CATALYS PRECISION LASER SYSTEM CATALYS OOE OPTIMEDICA CORPORATION CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other