BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 4173878 · Received October 1, 2014

    Report

    Report Number
    2028159-2014-01796
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ALCON ¿ IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A CORNEAL INCISION WOUND BURN OCCURRED DURING A CATARACT PROCEDURE. THE HANDPIECE WAS INSERTED UNDER THE VISCOELASTIC, AND UPON APPLICATION OF PHACOEMULSIFICATION (PHACO) AND VACUUM, THE LENS EMULSIFIED BUT WAS NOT ASPIRATING. AT THAT TIME, THE CORNEA INSTANTLY OPACIFIED AT THE MAIN INCISION, CONSISTENT WITH A CORNEAL BURN. IRRIGATION WAS NOTED TO HAVE BEEN "OKAY" PRIOR TO INSERTION. THE PACK AND PHACO HANDPIECE WERE CHANGED, HOWEVER, FLUIDICS WAS STILL NOT NORMAL. PHACO WAS NOTED TO BE SUCCESSFUL AND THE CASE WAS ABLE TO BE COMPLETED FOLLOWING SUTURE PLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT'S EYE WAS HIGHLY MOBILE AND MAY HAVE CONTRIBUTED TO THE EVENT. DURING THE PROCEDURE, A FLYING INSECT WAS BUZZING AROUND THE ROOM, AND THE PROCEDURE WAS STOPPED WHILE THE INSECT WAS REMOVED. DURING THIS TIME, THE EYE WAS COVERED AND EVERYTHING WAS PULLED DOWN AND RE-SCRUBBED. IT WAS NOTED THAT THE SURGEON USED A ROUTINE STOP AND CHOP TECHNIQUE. THE PATIENT REQUIRED RE-SUTURING ON (B)(6) 2014. THE PROGNOSIS IS "GOOD" PER THE SURGEON'S EVALUATION. THIS IS THE FIRST OF TWO REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610717 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON ¿ IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ANTERIOR PAK: 0.9, W/0 PROBE/IL| UNSPECIFIED ALCON HANDPIECE| DUOVISC| BSS, 30 DEGREES KELMAN MINI FLARED TIP