BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 2612525 · Received June 7, 2012

    Report

    Report Number
    3005675890-2012-00004
    Event Type
    Injury
    Date Received
    June 7, 2012
    Date of Event
    May 8, 2012
    Report Date
    June 7, 2012
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE INCIDENT INCLUDED ANALYSIS OF THE SYSTEM OPTICAL COHERENCE TOMOGRAPHY (OCT) RECORDING. NO SYSTEM VIDEO DISPLAY RECORDING WAS AVAILABLE FOR REVIEW. FROM THE ANALYSIS OF THE OCT RECORDING, IT WAS CONCLUDED THAT THE LASER CUTTING PATTERN FOR LENS FRAGMENTATION HAD BEEN DELIVERED MORE POSTERIOR THAN THE OPTIMAL LOCATION IN THE EYE. THE INVESTIGATION CONCLUDED THERE WERE MULTIPLE FACTORS THAT MAY HAVE CAUSED AND/OR CONTRIBUTED TO THE INCIDENT: INCORRECT IDENTIFICATION OF POSTERIOR LENS CAPSULE BOUNDARY OF THE OCT-DISPLAYED IMAGE BY THE SYSTEM; COUPLED WITH THE OPERATING PHYSICIAN'S FAILURE TO PROPERLY CONFIRM THE POSTERIOR LENS CAPSULE BOUNDARY BEFORE ACTIVATING THE LASER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ANTERIOR CAPSULOTOMY AND LENS FRAGMENTATION WITH THE CATALYS SYSTEM (SYSTEM) EXPERIENCED A POSTERIOR RUPTURE OF THE LENS CAPSULE AND A DISPLACED LENS NUCLEUS. IT WAS ALSO REPORTED THAT THE OPERATING PHYSICIAN ASCRIBED THE INCIDENT TO BE MOST LIKELY A RESULT OF USER ERROR BUT WANTED TO REPORT THE INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention