BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY VISION SYSTEM

    MDR report key: 3032725 · Received March 29, 2013

    Report

    Report Number
    2028159-2013-00591
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Report Date
    March 1, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING A 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. (B)(4).

    Description of Event or Problem · 1

    A PHARMACIST REPORTED THAT THE ASPIRATION TUBING APPEAR TO HAVE BEEN "CRUSHED". AS A CONSEQUENCE, THE ASPIRATION IS POOR. A COMPLETED QUESTIONAIRE WAS REC'D REPORTING THE IRRIGATION TUBING HAD BEEN FOLDED IN THE PACKAGING AND SEVERAL FOLD MARKS IN SEVERAL AREAS OF THE TUBING WHICH PREVENTED BSS FLOW. THIS HAS MAINLY BEEN NOTICED DURING ASPIRATION MODE. ADD'L INFO HAS BEEN REQUESTED. THIS IS THE SECOND OF TWO REPORTS BEING FILED FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130379 INFINITY VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INTERPID PLUS BASIC PACK