BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1132618 · Received August 22, 2008

    Report

    Report Number
    2028159-2008-00305
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    June 19, 2007
    Report Date
    July 23, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR.
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO SAMPLES RETURNED FOR EVAL, AND NO ADD'L INFO PROVIDED BY THE CUSTOMER RELATED TO THE REPORTED EVENT. FOR THIS REASON, THERE IS INSUFFICIENT INFO TO REPLICATE OR CONFIRM THE REPORTED ISSUE, AND THE ROOT CAUSE IS THEREFORE UNK AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A POSTERIOR CAPSULE TEAR OCCURRED DURING POLISHING WITH THIS I/A TIP DURING SURGERY. THE SURGEON DECLINED TO COMPLETE A QUESTIONNAIRE AND REQUESTED THE I/A TIP BE RETURNED WITHOUT EVALUATING THE I/A TIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability