BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 3062933 · Received April 12, 2013

    Report

    Report Number
    3005675890-2013-00008
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 11, 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 AND SYSTEM OPTICAL COHERENCE TOMOGRAPHY (OCT) RECORDING. THE OPERATING ROOM SURGICAL VIDEO WAS NOT AVAILABLE FOR ANALYSIS. FROM THE ANALYSIS OF THE DATABASE AND THE SYSTEM OCT RECORDING THERE WERE NO ANOMALIES FOUND AND ALL SETTINGS AND PARAMETERS OF THE SYSTEM WERE FOUND TO BE WITHIN ACCEPTABLE LIMITS. IT WAS NOTED BY OPTIMEDICA PERSONNEL WHO WERE PRESENT DURING THE PROCEDURE THAT THE SURGEON DID USE CONTINUOUS CURVILINEAR CAPSULORHEXIS (CCC) TECHNIQUE TO EXTRACT THE CAPSULE DISC. SYSTEM DATABASE VIDEO IMAGES INDICATED THE ABSENCE OF OR MINIMAL HORIZONTAL EYE MOVEMENT DURING THE LASER TREATMENT. THE CATALYS SYSTEM PERFORMED AS DESIGNED; HOWEVER, THE CAUSE(S) OF THE ANTERIOR AND POSTERIOR TEAR IS UNK.

    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 THAT EXTENDED TO THE POSTERIOR DURING THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. THE LASER CUT ANTERIOR CAPSULOTOMY WAS REPORTED TO BE COMPLETE WITH THE CAPSULE DISC FREE FROM ATTACHMENTS. THE ANTERIOR CAPSULE TEAR WAS NOTED DURING REMOVAL OF THE CORTEX. THE SURGEON SUCCESSFULLY PLACED THE IL INTO THE CAPSULE BAG. NO ADDITIONAL COMPLICATIONS AND/OR MEDICAL INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157836 CATALYS PRECISION LASER SYSTEM CATALYS OOE OPTIMEDICA CORPORATION CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR