BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 4200177 · Received October 21, 2014

    Report

    Report Number
    2028159-2014-01939
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PHACO TIP (UNSPECIFIED PRODUCT) WAS RECEIVED FOR METAL PIECE ON IRIS AFTER SURGERY. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE CONDUCTED. BECAUSE A SAMPLE WAS NOT RETURNED, THE ROOT CAUSE FOR CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT A METAL PIECE WAS OBSERVED AT THE 4 O'CLOCK POSITION OF THE LEFT EYE'S IRIS DURING A POSTOPERATIVE EXAMINATION AFTER CATARACT SURGERY. THE SURGEON SUSPECTED THAT THE METAL PIECE WAS FROM THE PHACOEMULSIFICATION TIP. THE SURGEON DOES NOT PLAN TO REMOVE IT AT THIS TIME. NO PATIENT HARM WAS REPORTED. NO ADDITIONAL INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670372 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON-IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED PHACO TIP