BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 3820823 · Received May 8, 2014

    Report

    Report Number
    2028159-2014-00874
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    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 CRF 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PATIENT EXPERIENCED A THERMAL BURN DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT SURGERY. THE SYSTEM IS NEW TO THE SURGEON. IT WAS SUGGESTED THAT THE AUDIBLE TONE MIGHT NOT HAVE BEEN PROPERLY INTERPRETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279624 CENTURION VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other