BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 2669818 · Received July 20, 2012

    Report

    Report Number
    3005675890-2012-00006
    Event Type
    Malfunction
    Date Received
    July 20, 2012
    Date of Event
    June 22, 2012
    Report Date
    June 22, 2012
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS: INITIAL REPORT REFLECTED THE DATE THE REPORT WAS SUBMITTED TO FDA INSTEAD OF THE DATE THE INITIAL REPORTER PROVIDED THE INFORMATION ABOUT THE EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE INCIDENT INCLUDED THE ANALYSIS OF THE SYSTEM VIDEO DISPLAY RECORDING, SYSTEM OPTICAL COHERENCE TOMOGRAPHY (OCT) RECORDING, AND CATARACT SURGERY VIDEO FROM THIS PROCEDURE. FROM THE ANALYSIS OF THE SYSTEM DISPLAY RECORDING, THERE IS EVIDENCE THAT THE PT INTERFACE LOST SEAL WITH THE EYE DURING THE LASER PHACOFRAGMENTATION PROCEDURE DUE TO EXCESSIVE EYE/PT MOVEMENT. THE CATALYS SYSTEM PERFORMED AS DESIGNED, IE THE LASER ENERGY TURNED OFF WHEN THE PHYSICIAN LIFTED HIS FOOT OFF THE LASER FOOTSWITCH.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED AS TO ANY IMPACT OR NO INJURY WAS REPORTED. IN INITIAL REPORT, OTHER SERIOUS INJURY WAS SELECTED IN ERROR. THE CATEGORIES FOR OUTCOMES ATTRIBUTED TO ADVERSE EVENT ARE NOT APPLICABLE AS THIS IS A PRODUCT PROBLEM. MALFUNCTION IS THE CORRECT REPORTABLE EVENT. (B)(4)¿S INVESTIGATION SUBSEQUENTLY IDENTIFIED THAT THE CATALYST SYSTEM MAY HAVE A REMOTE POTENTIAL EVENT WHERE LOSS OF SUCTION DURING LASER FIRING COULD CREATE A HAZARDOUS SITUATION THAT MAY RESULT IN SCORING OF THE POSTERIOR CORNEAL SURFACE. THEREFORE (B)(4) WILL ISSUE AN ADVISORY NOTICE TO REINFORCE INSTRUCTIONS PROVIDED IN PRODUCT TRAINING AND IN THE OPERATOR¿S MANUAL REGARDING SUCTION LOSS DURING A PROCEDURE. IN ADDITION, (B)(4)WILL BE MAKING ENHANCEMENTS FOR DETECTING AND ALERTING THE USER OF PATIENT SUCTION LOSS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WHO UNDERWENT ANTERIOR CAPSULOTOMY AND LENS FRAGMENTATION WITH THE CATALYS SYSTEM (SYSTEM) EXPERIENCED A LOSS OF SUCTION AT THE PT INTERFACE DURING LASER PHACOFRAGMENTATION, WHICH RESULTED IN THE DECOUPLING OF THE PT INTERFACE FROM THE EYE. THE PHYSICIAN RECOGNIZED THE LOSS OF SUCTION AND IMMEDIATELY LIFTED HIS FOOT OFF THE LASER FOOTSWITCH TO TERMINATE THE DELIVERY OF LASER ENERGY. DURING SURGICAL REMOVAL OF THE CATARACT IN THE OPERATING ROOM, IT WAS OBSERVED THAT THERE WAS A FAINT SCORING OF THE SUPERIOR QUADRANTS OF THE POSTERIOR SIDE OF THE CORNEA. NO ADDITIONAL COMPLICATION(S) AND OR MEDICAL INTERVENTION WAS REPORTED.

    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 Other