BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 2947450 · Received February 1, 2013

    Report

    Report Number
    3005675890-2013-00003
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    December 6, 2012
    Report Date
    February 1, 2013
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 O.R. SURGICAL VIDEO. FROM THE ANALYSIS OF THE SYSTEM DATABASE THERE WAS NO ANOMALIES AND ALL SETTINGS AND PARAMETERS OF THE SYSTEM WERE FOUND TO BE WITHIN ACCEPTABLE LIMITS. FROM THE ANALYSIS OF THE SURGICAL VIDEO, IT WAS NOTED THE SURGEON DID NOT USE CONTINUOUS CURVILINEAR CAPSULORHEXIS (CCC) TECHNIQUE TO EXTRACT THE CAPSULE DISC. THE SURGICAL VIDEO SHOWED THE SURGEON REMOVED THE CAPSULE DISC BY ASPIRATION OF THE CAPSULOTOMY DISC RATHER THAN ADVANCING THE CAPSULE IN A CIRCUMFERENTIAL FASHION AND THAT THIS MAY HAVE CAUSED AND/OR CONTRIBUTED TO THE ANTERIOR CAPSULE TEAR. THE SPECIFIC CAUSE(S) OF THE ANTERIOR LENS CAPSULE TEAR 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 A PT WHO UNDERWENT ANTERIOR CAPSULOTOMY AND LENS FRAGMENTATION WITH THE CATALYS SYSTEM (SYSTEM) SUBSEQUENTLY EXPERIENCED AN ANTERIOR LENS CAPSULE TEAR DURING THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. NO ADDITIONAL COMPLICATION(S) AND/OR MEDICAL INTERVENTION WERE REPORTED. THE PT WAS SUCCESSFULLY IMPLANTED WITH AN INTRAOCULAR LENS AND THE SURGERY ENDED WITH NO OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44186 CATALYS PRECISION LASER SYSTEM CATALYS OOE OPTIMEDICA CORPORATION CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other