BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 3940579 · Received June 25, 2014

    Report

    Report Number
    3005675890-2014-00023
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 25, 2014
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS INCIDENT INCLUDED ANALYSIS OF THE SYSTEM DATABASE, THE SYSTEM OPTICAL COHERENCE TOMOGRAPHY (OCT) RECORDING, AND THE OPERATING ROOM SURGICAL VIDEO. THE SYSTEM VIDEO DISPLAY RECORDING WAS 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, HOWEVER, IT DID REVEAL WHAT MAY HAVE BEEN A LOSS OF FLUID FROM THE PATIENT INTERFACE AT CONCLUSION OF THE LASER TREATMENT. THE ANALYSIS OF THE OPERATING ROOM SURGICAL VIDEO SHOWED THE SURGEON DID NOT USE THE STANDARD CONTINUOUS CURVILINEAR CAPSULORRHEXIS (CCC) SURGICAL TECHNIQUE TO REMOVE THE CAPSULOTOMY DISC. ADDITIONALLY, THE OPERATING ROOM VIDEO SHOWED THE SURGEON INSERTED A CAPSULE TENSION RING. SEVERAL REQUESTS HAVE BEEN MADE OF THE SURGEON TO PROVIDE ADDITIONAL INFORMATION REGARDING THE RADIAL TEAR, BUT NO RESPONSE HAS BEEN RECEIVED. THE CAUSE(S) OF THE RADIAL CAPSULE TEAR IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ANTERIOR CAPSULOTOMY AND LENS FRAGMENTATION WITH THE CATALYST SYSTEM (SYSTEM) SUBSEQUENTLY EXPERIENCED A RADIAL CAPSULE TEAR IN THE OPERATING ROOM (O.R.) DURING THE SURGICAL PROCEDURE OR REMOVE THE CATARACT. NO ADDITIONAL COMPLICATIONS AND/OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369716 CATALYS PRECISION LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE OPTIMEDICA CORPORATION CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other