BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTM

    MDR report key: 4092040 · Received August 21, 2014

    Report

    Report Number
    3005675890-2014-00027
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    July 23, 2014
    Report Date
    August 21, 2014
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 OPERATING ROOM SURGICAL VIDEO WERE NOT AVAILABLE FOR ANALYSIS. FROM THE ANALYSIS OF THE SYSTEM DATABASE AND THE SYSTEM OCT RECORDING IT WAS DETERMINED THAT 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 ADDITIONAL INFO REGRADING THE CAPSULAR TEARS, BUT NO RESPONSE HAS BEEN RECEIVED BACK. UPON RECEIPT OF ADDITIONAL INFO FROM THE SURGEON, FURTHER INVESTIGATION WILL BE PERFORMED IN AN ATTEMPT TO IDENTIFY THE ROOT CAUSE OF THE CAPSULE TEARS. IF APPROPRIATE, A FOLLOW-UP MDR WILL BE FILED IN ACCORDANCE WITH THE 21 CFR 803.56 REGULATIONS. THE CATALYS SYSTEM PERFORMED AS DESIGNED; HOWEVER THE CAUSE(S) OF THE CAPSULAR TEARS 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 CAPSULAR TEARS IN THE OPERATING ROOM (OR) DURING THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. NO ADDITIONAL COMPLICATIONS AND/OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504939 CATALYS PRECISION LASER SYSTM OPHTHALMIC FEMTOSECOND LASER OOE OPTIMEDICA CORPORATION CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other