BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYS OZIL

    MDR report key: 3881135 · Received April 9, 2014

    Report

    Report Number
    2028159-2014-00620
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    ALCON -IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE SYSTEM WOULD NOT RELEASE THE CAPSULE DURING A SURGICAL PROCEDURE. THE SURGEON DID NOT HAVE HIS FOOT COMPLETELY RELEASED FROM THE FOOTPEDAL AND WHEN RELEASED THE FOOTPEDAL COMPLETELY THE CAPSULE WAS RELEASED. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214190 INFINITI VISION SYS OZIL PHACOFRAGMENTATION SYS HQC ALCON -IRVINE TECH CTR INFINIT OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1