BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 2915067 · Received January 10, 2013

    Report

    Report Number
    3005675890-2013-00002
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 10, 2013
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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, SYSTEM VIDEO DISPLAY RECORDING AND OPERATING ROOM SURGICAL VIDEO. FORM THE ANALYSIS OF THE SYSTEM DISPLAY RECORDING AND THE SYSTEM DATABASE THERE WERE NO ANOMALIES AND ALL SETTINGS AND PARAMETERS OF THE SYSTEM WERE FOUND TO BE WITHIN ACCEPTABLE LIMITS. FORM THE ANALYSIS OF THE SURGICAL VIDEO IT WAS NOTED THE SURGEON DID NOT USE CONTINUOUS CURVILINEAR CAPSULORRHEXIS (CCC) TECHNIQUE TO EXTRACT 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 UNKNOWN. THE CATALYST 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 PATIENT WHO UNDERWENT ANTERIOR CAPSULOTOMY, LENS FRAGMENTATION, AND CORNEAL INCISIONS WITH THE CATALYS SYSTEM (SYSTEM) SUBSEQUENTLY EXPERIENCED AN ANTERIOR LENS CAPSULE TEAR DURING THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. IT WAS NOTED THAT THE PHYSICIAN DID NOT USE THE OPTIMREDICA RECOMMENDED CONTINOUS CURVILINEAR CAPSULORRHEXIS (CCC) CAPSULOTOMY DISC REMOVAL TECHNIQUE TO EXTRACT THE CAPSULOTOMY DIS. THE SURGEON NOTICED THE TEAR AFTER THE COMPLETION OF THE PHACOEMULSIFICATION PROCEDURE. NO ADDITIONAL COMPLICATION(S) AND/OR MEDICAL INTERVENTION WERE REPORTED. THE PATIENT 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
    15451 CATALYS PRECISION LASER SYSTEM CATALYS OOE OPTIMEDICA CORPORATION CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other