BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1012677 · Received March 12, 2008

    Report

    Report Number
    2523835-2008-00003
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 11, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POSTERIOR CAPSULE TEAR IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A POSTERIOR CAPSULE (PC) TEAR OCCURRED DURING I/A POLISH. THE SURGEON SUSPECTS A ROUGH I/A HANDPIECE TIP. THE SURGEON PERFORMED AN ANTERIOR VITRECTOMY. THE PT OUTCOME IS EXCELLENT. THE SURGEON HAD TWO INCIDENTS THE SAME DAY WITH THE SAME HANDPIECE. WHEN HE STOPPED USING THAT HANDPIECE HE DIDN'T HAVE ANYMORE EVENTS. THIS REPORT IS FOR ONE PT; FOR ADD'L PT SEE MFG. REPORT #: 2523835-2008-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM OPHTHALMIC SURGERY SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention| S