BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPS FX PHACO HANDPIECE

    MDR report key: 3251100 · Received July 29, 2013

    Report

    Report Number
    2020664-2013-00070
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCOUNT REPORTED THAT SYMPTOMATIC STATES WERE SUBSIDED BY PRESCRIBING STEROID. THEY ALSO SAID THAT CAUSE OF THE INCIDENT COULD NOT BE IDENTIFIED; ALTHOUGH, SURGEON SPECULATES THAT ONE OF THE PROBABLE CAUSES COULD BE DE-NATURALIZING OF THE OPTHALMIC VISCOELASTIC DEVICE RESIDING WITHIN IRRIGATION/ASPIRATION HANDPIECE DUE TO INSUFFICIENT CLEANING. THERE ARE FIVE IRRIGATION/ASPIRATION HANDPIECES AT THE CUSTOMER SITE THAT ARE REUSED AFTER STERILIZING.

    Additional Manufacturer Narrative · 1

    ACCOUNT REPORTED TO SALES REPRESENTATIVE (SR) THAT THEY WERE USING AN AUTOMATIC SURGICAL INSTRUMENT CLEANING MACHINE MADE BY (B)(4) TO PERFORM ULTRASONIC CLEANING OF I/A HANDPIECE AND THE MACHINE USES DETERGENTS AND ANTI-CORROSIVE AGENTS. THIS IS CONTRARY TO THE INSTRUCTIONS FOUND IN THE DIRECTIONS FOR USE PROVIDED WITH THE PRODUCT. THE CUSTOMER THOUGHT THESE SUBSTANCES MAY RESIDE WITHIN THE CANNULA. UPON REVIEWING THE CLEANING PROCEDURE DIRECTIONS FOR USE (DFU) AFTER THE INCIDENTS, THE CUSTOMER HAS DECIDED TO CLEAN THEM WITHOUT ADDING DETERGENTS AND ANTI-CORROSIVE AGENTS. ON A LATER VISIT THE ACCOUNT REPORTED TO SR THAT THE HANDPIECES ARE CLEANED FOLLOWING THE DFU; ULTRASONIC CLEANING WAS NOT USED.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION VISUAL INSPECTION REVEALED THE PRODUCT WAS IN GOOD PHYSICAL CONDITION. FAILURES DUE TO POWER BELOW SPECIFICATION ARE DUE TO A NEW SPECIFICATION IMPLEMENTED IN MAY 2011 (AFTER THE DEVICE WAS MANUFACTURED AND RELEASED) BY ABBOTT MEDICAL OPTICS (AMO). AS PER AMO USA, HORN WAS REPLACED WITH CURRENT DESIGN AND PERFORMED FINAL TEST. MANUFACTURER IS UNABLE TO VERIFY THIS TYPE OF COMPLAINT. FROM THE INVESTIGATION, THEY WERE UNABLE TO DETERMINE ROOT CAUSE FOR COMPLAINT. PLACEHOLDER.

    Description of Event or Problem · 1

    ONE DAY POST OPERATION, THE SYMPTOMATIC STATES OF TASS (TOXIC ANTERIOR SEGMENT SYNDROME) WERE OBSERVED. NO HISTORY OF PREVIOUS ILLNESS OR NO COMPLICATING DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352362 ELLIPS FX PHACO HANDPIECE PHACO HANDPIECE HQC ABBOTT MEDICAL OPTICS 690880

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other OPEGAN HI AND VISCOAT