BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYS

    MDR report key: 3839268 · Received May 20, 2014

    Report

    Report Number
    3005675890-2014-00017
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 FOUND AND ALL OPERATING 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. ANALYSIS OF THE OCT RECORDING ALSO SHOWED THAT THE POSTERIOR LENS CAPSULE HAD BEEN CORRECTLY IDENTIFIED BY THE SURGEON AND THAT A 500UM SAFETY MARGIN WAS EMPLOYED. FROM THIS INFO IT CAN BE CONCLUDED THAT THE SYS LASER DID NOT PENETRATE OR OTHERWISE COMPROMISE THE INTEGRITY OF THE POSTERIOR LENS CAPSULE. ACCORDING TO THE SURGEON, AN INCREASED TENSION ON THE CAPSULE FROM AIR BUBBLES IN ADDITION TO THE HYDRODISSECTION MAY HAVE CONTRIBUTED TO THE POSTERIOR BREAK IN THE LENS CAPSULE. THE CATALYS SYS PERFORMED AS DESIGNED, HOWEVER, THE CAUSE (S) OF THE POSTERIOR CAPSULE TEAR IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WHO UNDERWENT ANTERIOR CAPSULOTOMY, LENS FRAGMENTATION, AND CORNEAL INCISIONS WITH THE CATALYS SYS (SYS) SUBSEQUENTLY EXPERIENCED A POSTERIOR CAPSULE TEAR IN THE OPERATING ROOM DURING THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. A POSTERIOR CAPSULE TEAR WAS SUSPECTED WHEN THE SURGEON NOTED THE DENSE CATARACT WAS UNSTABLE DURING THE MANIPULATION OF IT WITH HYDRODISSECTION. A VITRECTOMY WAS PERFORMED. ADDITIONALLY, THE SURGEON CREATED A SCLERAL TUNNEL AND PERFORMED AN EXTRACAPSULAR REMOVAL OF THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298668 CATALYS PRECISION LASER SYS OPHTHALMIC FEMTOSECOND LASER OOE OPTIMEDICA CORPORATION CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other