BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 3181966 · Received June 17, 2013

    Report

    Report Number
    2028159-2013-01106
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    February 26, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT RETURNING FOR EVALUATION. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE TUBING WAS PINCHED CAUSING LOWER LIQUID FLOW DURING A CATARACT EXTRACTION PROCEDURE. THE CASSETTE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273514 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR INFINITI BASIC PAK