BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 3780671 · Received April 18, 2014

    Report

    Report Number
    3005675890-2014-00013
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 18, 2014
    Manufacturer
    OPTIMEDICA CORPORAION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS INCIDENT INCLUDED ANALYSIS OF THE SYSTEM DATABASE AND THE SYSTEM OPTICAL COHERENCE TOMOGRAPHY (OCT) RECORDING. THE SYSTEM VIDEO DISPLAY RECORDING AND THE OR SURGICAL VIDEO WERE NOT AVAILABLE FOR ANALYSIS. FROM THE ANALYSIS OF THE SYSTEM DATABASE AND THE SYSTEM OCT RECORDING THERE WERE NO SYSTEM RELATED ANOMALIES OBSERVED AND ALL SETTINGS AND PARAMETERS OF THE SYSTEM WERE FOUND TO BE WITHIN ACCEPTABLE LIMITS. THE SYSTEM DATABASE VIDEO IMAGES INDICATED THE ABSENCE OF, OR MINIMAL, EYE MOVEMENT DURING THE LASER TREATMENT. SEVERAL REQUESTS HAVE BEEN MADE OF THE SURGEON TO PROVIDE ADD'L INFO REGARDING THE REASON FOR THE VITRECTOMY BUT NO RESPONSE HAS BEEN RECEIVED. UPON RECEIPT OF ADD'L INFO FROM THE SURGEON, FURTHER INVESTIGATION WILL BE PERFORMED IN AN ATTEMPT TO IDENTIFY THE ROOT CAUSE FOR THE VITRECTOMY. IF APPROPRIATE, A FOLLOW-UP MDR WILL BE FILED IN ACCORDANCE WITH THE 21 CFR 803.56 REGULATIONS. THE SYSTEM PERFORMED AS DESIGN; HOWEVER, THE CAUSE (S) FOR THE VITRECTOMY IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ANTERIOR CAPSULOTOMY AND LENS FRAGMENTATION WITH THE CATALYS SYSTEM REQUIRED A VITRECTOMY IN THE OPERATING ROOM (O.R.) DURING THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. NO ADD'L COMPLICATION AND/OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239009 CATALYS PRECISION LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE OPTIMEDICA CORPORAION CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other