BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2842022 · Received November 12, 2012

    Report

    Report Number
    2028159-2012-01757
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SVC. NO SAMPLES WERE RETURNED THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLACE OR CONFIRM THE REPORTED EVENT. THE SYSTEM IS EQUIPPED WITH VISUAL AND AUDIBLE WARNINGS 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. BECAUSE FRICTION IS THE DOMINANT VARIABLE FOR GENERATING HEAT, CONTINUOUS LONGITUDINAL ULTRASOUND IS THE LEAST DESIRABLE OPTION. DELIVERING PULSES OR BURSTS OF ULTRASOUND ENERGY CAN REDUCE TOTAL ENERGY, AS CAN INCREASING OFF TIME BY LOWERING DUTY CYCLE. USING TORSIONAL AMPLITUDE IS ANOTHER EXTREMELY EFFECTIVE METHOD IN REDUCING HEAT WITH THE INCISION. AFTER THOROUGH ANALYSIS OF THE REPORTED EVENTS, DETERMINATION OF THE DIRECT CAUSE OF THE CORNEAL THERMAL INJURY WAS INCONCLUSIVE. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS ON THIS SYSTEM. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE PENNSYLVANIA PT 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 MALFUNCTION EQUIPMENT. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PT EXPERIENCED A CORNEAL BURN DURING SURGERY. A COMPLETED QUESTIONNAIRE WAS RETURNED INDICATING THE INCIDENT OCCURRED UPON INITIAL INSERTION OF THE PHACO HANDPIECE IN THE LEFT EYE AND OCCURRED IN THE PRESENCE OF OPHTHALMIC VISCOSURGICAL DEVICE (OVD) IN THE ANTERIOR CHAMBER. THREE SUTURES WERE PLACED AT THE MAIN INCISION TO SEAL THE LEAKY WOUND. THERE WERE NO REPORTS OF THE OCCLUSION TONE BEING HEARD WHEN THE EVENT TRANSPIRED. IN THE SURGEON'S OPINION, THE FOLLOWING CAUSED/CONTRIBUTED TO THE EVENT: OCCLUSION-FORM OVD; PHACO POWER, HANDPIECE, INSUFFICIENT IRRIGATION. ONE WEEK POSTOPERATIVE, CORNEAL EDEMA WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention VISCOAT