BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 2896387 · Received December 28, 2012

    Report

    Report Number
    3005675890-2012-00017
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 28, 2012
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Product Problem
    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 RECORDS, SYSTEM OPTICAL COHERENCE TOMOGRAPHY (OCT) RECORDING, SYSTEM VIDEO DISPLAY RECORDING FROM THIS PROCEDURE; OPERATING ROOM SURGICAL VIDEO WAS NOT AVAILABLE FOR ANALYSIS. FROM THE ANALYSIS OF THE SYSTEM DATABASE AND SYSTEM RECORDS IT WAS DETERMINED THAT AN INADVERTENT DEVIATION FROM THE DESIGNATED WRITTEN SERVICE PROCEDURE RESULTED IN A MISALIGNMENT OF THE LASER. THE LASER ALIGNMENT ERROR WAS SUBSEQUENTLY CORRECTED PRIOR TO THE NEXT DAY OF SURGERY. THE CAPSULOTOMY WAS REPORTED TO HAVE SOME RESIDUAL ATTACHMENTS. SINCE THE OPERATING ROOM VIDEO WAS NOT AVAILABLE FOR REVIEW, IT IS UNCLEAR IF THE SURGEON USED THE RECOMMENDED STANDARD CONTINUOUS CURVILINEAR CAPSULORRHEXIS (CCC) TECHNIQUE TO REMOVE THE CAPSULOTOMY DISC. THE SPECIFIC CAUSE(S) OF THE ANTERIOR LENS CAPSULE TEAR ARE UNKNOWN. 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 PATIENT WHO UNDERWENT ANTERIOR CAPSULOTOMY, LENS FRAGMENTATION, AND CORNEAL INCISIONS WITH THE CATALYS SYSTEM (SYSTEM) SUBSEQUENTLY EXPERIENCED AN ANTERIOR LENS CAPSULE TEAR SOMETIME DURING THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. THE ANTERIOR CAPSULE TEAR WAS NOTED AFTER REMOVAL OF THE LENS AND CORTEX. THE SURGEON PLACED THE IOL IN THE SULCUS. NO ADDITIONAL COMPLICATION(S) AND/OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other