BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2982467 · Received February 26, 2013

    Report

    Report Number
    2028159-2013-00304
    Event Type
    Injury
    Date Received
    February 26, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY CLINICAL ANALYST REVIEWED THIS FILE AND NOTED: A COMPLAINT REPORT WAS FILED WHEREIN A CORNEAL THERMAL INJURY OCCURRED WHILE PERFORMING CATARACT SURGERY UTILIZING TRADITIONAL LONGITUDINAL ULTRASOUND ON GRAD 3 SETTINGS FOR WHAT WAS DESCRIBED AS VERY DENSE CATARACTS. IT WAS REPORTED THAT THERE WAS SLIGHT WARMING OF THE HANDPIECE AND THAT THE MACHINE DEALT WITH THE LENS FRAGMENTS FINE BUT AT AN UNSPECIFIED TIME POINT INCISION SITE HAS OCCURRED. IT WAS ALSO STATED THAT THE THERMAL INCISION INJURY DID SEAL WITH WOUND HYDRATION BUT IT APPEARED AS POUTING SO A SUTURE WAS PLACED FOR REASSURANCE. THE UNIVERSAL WARNING SIGN OF THERMAL INJURY IS THE APPEARANCE OF VISIBLE LENS PARTICLES (LENS MILK) WHICH REPRESENT STAGNANT EMULSION NOT BEING ASPIRATED. THE SURGEON MAY ALSO NOTICE THE LACK OF CUTTING ACTIVITY OR LENS MOVEMENT WHEN THE TIP IS OBSTRUCTED. THE SURGEON MUST IMMEDIATELY ABORT THE EMULSIFICATION BY DECELERATING THE FOOT PEDAL INTO IRRIGATION AND ASPIRATION MODE IN ORDER TO AVOID A RAPID TEMPERATURE RISE. WARNING BEEPS OR AUDIBLE TONES ALERT THE SURGEON TO AN INTERRUPTION OF FLOW CAN BE VERIFIED BY THE NURSE WHO QUICKLY CONFIRMS THE ABSENCE OF ACTIVITY IN THE DRIP CHAMBER. THE SYSTEM IS EQUIPPED WITH VISUAL AND AUDIBLE WARNING SIGNALS TO ALERT THE USER OF AN OCCLUSION; HOWEVER THE SURGEON MUST RECOGNIZE THE SIGNAL AND MANUALLY STOP THE ULTRASOUND MODE. THE SYSTEM ALSO ALLOWS THE SURGEON TO MODULATE ULTRASOUND ENERGY. THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID INDICATE ONE SIMILAR REPORT FOR THIS SYSTEM. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE PENNSYLVANIA PATIENT SAFETY ADVISORY ABSTRACT: PREVENTING CORNEAL BURNS DURING PHACOEMULSIFICATION, MARCH 2010, VOL. 7, NO. 1: 23-25, MOST CORNEAL BURNS CAN BE TRACED TO ISSUES RELATED TO SURGICAL TECHNIQUE AND NOT TO MALFUNCTIONING EQUIPMENT. A ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED A PATIENT EXPERIENCED A CORNEAL BURN DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THE SURGEON PROVIDED THAT THE PATIENT HAD A DENSE NUCLEAR CATARACT WHICH WAS REMOVED ON GRADE THREE SETTINGS. DURING THE PROCEDURE, THERE WAS SLIGHT WARMING OF THE HAND PIECE, AND THE MACHINE DEALT WITH THE FRAGMENTS FINE, HOWEVER THERE WAS A BURN TO THE CORNEAL WOUND. THE BURN SEALED WITH HYDRATION, HOWEVER A SUTURE WAS PLACED TO ENSURE CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81032 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention