BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAUREATE WORLD PHACO SYSTEM

    MDR report key: 2822679 · Received November 2, 2012

    Report

    Report Number
    2028159-2012-01705
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 6, 2012
    Report Date
    October 7, 2012
    Manufacturer
    ALCON -IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD¿L INFO 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 24 MONTHS DID NOT INDICATE ANY ADD¿L SIMILAR REPORTS FOR THIS SYSTEM OR ANTERIOR VITRECTOMY HAND PIECE. THE CUSTOMER STATED THE POSTERIOR CAPSULE TEAR WAS NOT RELATED TO ANY ALCON PRODUCT. POSTERIOR CAPSULE TEAR IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. HOWEVER, A REVIEW OF THE COMPLAINT TRENDS SHOWS THAT THE FREQUENCY REPORTED IS WITHIN KNOWN LEVELS FOR THIS EVENT. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A MEDICAL DOCTOR REPORTED THAT THE CUTTER PORT DID NOT ACTUATE EVEN ON FULL DEPRESSION OF THE FOOTSWITCH DESPITE RECONNECTION OF THE HAND PIECE AND ADJUSTMENT OF THE CUT RATE PARAMETERS DURING A VITRECTOMY PROCEDURE. FOLLOWING A 20-30 MINUTE DELAY FOR TROUBLESHOOTING, AN ALTERNATE SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT HARM. ADD¿L INFO WAS RECEIVED ADVISING THAT THE POSTERIOR CAPSULE TEAR OCCURRED DURING PHACOEMULSIFICATION ON A HYPER MATURE, HYPEROPIC CATARACT. THE SURGEON DOES NOT SEE ANY RELATION OF THE TEAR WITH ANY OF THE MFR¿S PRODUCT. A POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) IS IMPLANTED INSIDE THE POSTERIOR CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAUREATE WORLD PHACO SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON -IRVINE TECHNOLOGY CENTER LAUREATE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LAUREATE ANTERIOR VITRECTOMY HANDPIECE