BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYS

    MDR report key: 3851100 · Received May 22, 2014

    Report

    Report Number
    3005675890-2014-00018
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 22, 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, THE SYSTEM VIDEO DISPLAY RECORDING, AND THE OPERATING ROOM SURGICAL VIDEO. 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 SURGEON SELECTED CUSTOM FITTING FOR ANTERIOR/POSTERIOR CORNEA, LENS ANTERIOR/POSTERIOR, AND IRIS. ANALYSIS OF THE SYS OCT IMAGES SHOWED THAT THE CUSTOM FITS MADE BY THE SURGEON FOR THE ANTERIOR CORNEA AND POSTERIOR CORNEA WERE NOT IDEAL DUE TO THE IRREGULAR SHAPE OF THE CORNEA. ANALYSIS OF THE SYSTEM VIDEO DISPLAY RECORDING SHOWED THAT A SUDDEN RELEASE (I.E. BLOWOUT) OF FLUID FROM THE CAPSULAR BAG OCCURRED DURING THE CAPSULOTOMY TREATMENT. FURTHERMORE, ANALYSIS OF THE OPERATING ROM SURGICAL VIDEO SHOWED THAT THE SURGEON DID NOT USE THE STANDARD CONTINUOUS CURVILINEAR CAPSULORRHEXIS (CC) TECHNIQUE TO REMOVE THE CAPSULOTOMY DISC AND THAT THE ANTERIOR CAPSULE TEAR WAS OBSERVED DURING THE REMOVAL OF THE DISC. THE CATALYST SYSTEM PERFORMED AS DESIGN; HOWEVER, THE CAUSE(S) OF THE ANTERIOR CAPSULE TEAR IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WITH DOWN'S SYNDROME WHO UNDERWENT ANTERIOR CAPSULOTOMY AND LENS FRAGMENTATION WITH THE CATALYST SYSTEM (SYSTEM) SUBSEQUENTLY EXPERIENCED AN ANTERIOR CAPSULE TEAR IN THE OPERATING ROOM (OR) DURING THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. NO ADDITIONAL MEDICAL INTERVENTION AND/OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306557 CATALYS PRECISION LASER SYS OPHTHALMIC FEMTOSECOND LASER OOE OPTIMEDICA CORPORATION CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other