BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1963330 · Received January 14, 2011

    Report

    Report Number
    2028159-2010-02475
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    November 17, 2010
    Report Date
    December 16, 2010
    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
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A TIP BURR RESULTING IN A RUPTURED POSTERIOR CAPSULE WERE FOUND. THE PRODUCT WAS RELEASED ACCORDING TO THE ALCON'S ACCEPTANCE CRITERIA. ROOT CAUSE: BECAUSE A SAMPLE WAS NOT RETURNED TO SUPPORT THE PRESENCE OF A BURR ON THE POLYMER I/A TIP AND NO EVIDENCE OF NONCONFORMITY COULD BE FOUND IN THE LOT RECORD REVIEW, THE ROOT CAUSE FOR THE POSTERIOR CAPSULE RUPTURE CANNOT BE DETERMINED. IT IS UNCLEAR HOW THE PRODUCT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT BASED ON THE PRODUCT MEETING ALL MANUFACTURING SPECIFICATIONS. BECAUSE THE ROOT CAUSE IS UNK, NO MALFUNCTIONS WERE CONFIRMED AND NO SIMILAR INCIDENTS CAN BE IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A POSTERIOR CAPSULE TEAR OCCURRED DURING THE POLISH MODE, AND IT IS SUSPECTED THAT THERE WAS A BURR ON THE IRRIGATION/ASPIRATION TIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other