BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2950059 · Received February 6, 2013

    Report

    Report Number
    2028159-2013-00138
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND DETERMINED THAT ASPIRATION WAS NOT PERFORMING OPTIMALLY WHILE USING THE CUSTOMER'S HANDPIECE (HP). THE COMPANY REPRESENTATIVE ADVISED THE CUSTOMER TO REVIEW THE PROCEDURE OF PROPER HP FLUSHING AFTER EACH CASE, AND COMPLETED A FLUSHING OF THE HP AND TIP FOR THE CUSTOMER WHILE ON-SITE. PREVENTIVE MAINTENANCE (PM) WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF THE SYSTEM'S EVENT LOG FOR THE DATE OF (B)(4) 2013, DID NOT REVEAL ANY ISSUES RELATED TO THE CUSTOMER REPORTED EVENT OF SYSTEM NOT ASPIRATING. THE SYSTEM'S DIRECTIONS FOR USE (DFU) STATES THAT FOR HANDPIECE CARE, THE HANDPIECE MUST BE ROUGHLY CLEANED IMMEDIATELY FOLLOWING A SURGERY. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE AN ADDITIONAL SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE HANDPIECE CLEANING PROCESS PERFORMED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THE UNIT WAS NOT ASPIRATING. THE HANDPIECE AND CASSETTE WERE EXCHANGED, BUT THE SURGEON HAD TO CONVERT TO EXTRACAPSULAR CATARACT EXTRACTION TO COMPLETE THE CASE. THERE WAS A SURGICAL DELAY OF SEVEN MINUTES. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50102 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other