BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 2471822 · Received February 23, 2012

    Report

    Report Number
    3005675890-2012-00002
    Event Type
    Injury
    Date Received
    February 23, 2012
    Date of Event
    January 25, 2012
    Report Date
    February 23, 2012
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE INCIDENT INCLUDED ANALYSIS OF THE CATARACT SURGERY VIDEO. FROM THIS ANALYSIS, IT WAS CONFIRMED THAT THERE WAS AN ANTERIOR CAPSULE TEAR. HOWEVER, IT COULD NOT BE CONCLUSIVELY DETERMINED THAT THE ANTERIOR CAPSULE TEAR OCCURRED AT THE TIME OF CAPSULOTOMY DISC REMOVAL, OR LATER DURING THE REMOVAL OF THE LENS WHEN PERFORMING ULTRASOUND PHACOEMULSIFICATION. THE ANTERIOR CAPSULE TEAR IS BEST VISUALIZED INITIALLY WHEN THE FIRST QUADRANT OF THE LENS IS PULLED ANTERIORLY DURING THE PHACOEMULSIFICATION PORTION OF THE CATARACT SURGERY. THE VIDEO ANALYSIS ALSO CONFIRMED THAT THE ANTERIOR CAPSULE TEAR EXTENDED TO THE POSTERIOR CAPSULE AND THAT AN ANTERIOR VITRECTOMY WAS PERFORMED. THE PRECISE TIME COURSE OF THE EXTENSION OF THE ANTERIOR TEAR TO THE POSTERIOR OF THE CAPSULE COULD NOT BE CONCLUSIVELY DETERMINED, BUT IS LIKELY TO HAVE OCCURRED DURING ULTRASOUND PHACOEMULSIFICATION. THE CATARACT SURGERY WAS COMPLETED WITH THE SUCCESSFUL IMPLANT OF A SINGLE-PIECE INTRAOCULAR LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WHO UNDERWENT SUCCESSFUL ANTERIOR CAPSULOTOMY AND LENS FRAGMENTATION WITH THE CATALYS SYSTEM EXPERIENCED AN ANTERIOR CAPSULE TEAR WHEN THE SURGEON REMOVED THE CAPSULOTOMY DISC. THE ANTERIOR CAPSULE TEAR SUBSEQUENTLY EXTENDED TO THE POSTERIOR CAPSULE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention