BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPS T-PHACO HANDPIECE

    MDR report key: 3914314 · Received July 3, 2014

    Report

    Report Number
    2020664-2014-00050
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER REPORT NUMBER SHOULD HAVE BEEN (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PT AGE: NOT PROVIDED, AS TO NO INFORMATION WAS PROVIDED. DATE OF EVENT - NOT PROVIDED, AS TO NO INFORMATION WAS PROVIDED. (B)(4). DEVICE HAS NOT BEEN RETURNED AT THE TIME OF THIS REPORT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS REPLACED AND RETURNED TO THE MANUFACTURER FOR EVALUATIONS. THE MANUFACTURER VISUALLY INSPECTED THE PRODUCT AND FOUND THE HANDPIECE TO BE IN GOOD CONDITION. THE HANDPIECE WAS FUNCTIONALLY TESTED. THE TESTING OF THE HANDPIECE WAS THAT IT PASSED ALL TEST REQUIREMENTS. THE ASPIRATION LUMEN SHOWED NO SIGNS OF BEING CLOGGED. THE HANDPIECE STROKE MEETS SPECIFICATIONS. THERE WAS NO HEATING NOTED DURING TESTING OF THE HANDPIECE AND TIP. THEREFORE, THE SUSPECTED HANDPIECE WAS EVALUATED VISUALLY AND FUNCTIONAL BY (B)(4) AND NO OBSERVATIONS WERE NOTICED. MOOG WAS UNABLE TO CONFIRM THE REPORTED THE PROBLEM. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    IN FOLLOW-UP#1, THE MANUFACTURER ADDRESS SHOULD HAVE BEEN ADDED AND CORRECTED. THE ADDRESS HAS BEEN PROVIDED IN THIS FOLLOW UP. IN FOLLOW-UP#1, THE DATE WAS NOT PROVIDED AS IT SHOULD HAVE BEEN (B)(4) 2014. IN FOLLOW-UP#2, DEVICE EVALUATION IS THE CORRECT SELECTION. ADDITIONAL CONCLUSION CODE HAS BEEN PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A CATARACT EXTRACTION PROCEDURE THE CLINIC REPORTED A CORNEAL BURN OCCURRED IN THE PATIENT'S OPERATIVE EYE DUE TO HANDPIECE HEATING UP. THE WOUND REQUIRED UNPLANNED SUTURES TO CLOSE THE INCISION. THE PATIENT IS EXPECTED TO HAVE A GOOD OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389653 ELLIPS T-PHACO HANDPIECE PHACO HANDPIECE HQC ABBOTT MEDICAL OPTICS 690858

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention