BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 2073579 · Received April 27, 2011

    Report

    Report Number
    2028159-2011-00450
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE CUSTOMER REPORTED EVENT. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO PARTS ARE RETURNING FOR EVAL. THE ROOT CAUSE IS UNK. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 04/27/2011. (B)(4).

    Description of Event or Problem · 1

    A SCRUB TECH REPORTED PROBLEMS WITH THE HANDPIECES AND CARTRIDGES WHICH HAD RESULTED IN TWO CASES OF CORNEAL BURNS. THE TECH ALSO STATED THE SURGEON INDICATED DURING THE FIRST CASE, THE HANDPIECE WAS TOO HOT AND THAT HE HAD REQUESTED THE HANDPIECE BE SWITCHED OUT. WHEN THE TIP OF THE HANDPIECE WAS REMOVED FROM THE EYE, A BURN WAS NOTED. THE SECOND HANDPIECE WAS USED TO COMPLETE THE CASE. THE SYSTEM WAS REPORTED TO HAVE BEEN EXCHANGED DURING ONE OF THE CASES, HOWEVER, THE TECH WAS UNSURE OF WHICH CASE. CORNEAL EDEMA WAS ALSO REPORTED TO HAVE OCCURRED IN ONE OF THE TWO CASES REPORTED. ADDITIONAL INFO REGARDING PT STATUS, IDENTIFIERS, AND ADDITIONAL EVENT DETAILS HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention