BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 2992895 · Received March 2, 2013

    Report

    Report Number
    3005675890-2013-00006
    Event Type
    Injury
    Date Received
    March 2, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 2, 2013
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE INCIDENT INCLUDED THE ANALYSIS OF THE SYSTEM DATABASE AND SYSTEM OPTICAL COHERENCE TOMOGRAPHY (OCT) RECORDING. NO OPERATING ROOM SURGICAL VIDEO WAS AVAILABLE FOR ANALYSIS. FROM THE ANALYSIS OF THE SYSTEM DATABASE THERE WERE NO ANOMALIES AND ALL SETTINGS AND PARAMETERS OF THE SYSTEM WERE FOUND TO BE WITHIN ACCEPTABLE LIMITS. ANALYSIS OF THE SYSTEM OCT RECORDINGS SHOWED THAT THE POSTERIOR LENS CAPSULE WAS CORRECTLY IDENTIFIED BY THE SYSTEM AND THAT A 700UM SAFETY MARGIN WAS EMPLOYED. FROM THIS INFO IT CAN BE CONCLUDED THAT THE SYSTEM LASER DID NOT PENETRATE OR OTHERWISE COMPROMISE THE INTEGRITY OF THE POSTERIOR LENS CAPSULE. SERVICE PERSONNEL ALSO EVALUATED THE SYSTEM ON SITE AND CONFIRMED THAT THE SYSTEM WAS PERFORMING WITHIN SPECIFICATIONS WITH NO ANOMALIES NOTED. IT IS UNK WHETHER OR NOT THE REPORTED POSTERIOR LENS CAPSULE RUPTURE WAS INITIALLY PROCEEDED BY AN ANTERIOR CAPSULE TEAR THAT MAY HAVE EXTENDED TO THE POSTERIOR OF THE LENS CAPSULE. IT IS ALSO UNK IF THE SURGEON USED STANDARD CONTINUOUS CURVILINEAR CAPSULORRHEXIS (CCC) SURGICAL TECHNIQUE TO REMOVE THE LENS CAPSULOTOMY DISC. 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 A POSTERIOR LENS CAPSULE RUPTURE DURING THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. THE SURGEON FURTHER NOTED THAT THE POSTERIOR CAPSULE WAS TORN DURING IMPLANTATION OF THE INTRA OCULAR LENS (IOL). NO ADDITIONAL COMPLICATION(S) AND/OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90560 CATALYS PRECISION LASER SYSTEM CATALYS OOE OPTIMEDICA CORPORATION CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR