BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 8647750 · Received May 28, 2019

    Report

    Report Number
    2028159-2019-00945
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    April 30, 2019
    Report Date
    July 23, 2019
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K161794
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO EVIDENCE CONTAINED WITHIN THE REPORTED INFORMATION AT THIS TIME THAT INDICATES THAT THE DESIGN OR PERFORMANCE OF THE SYSTEM HAD ANY EFFECT ON THE INTEGRITY OF THE POSTERIOR CAPSULE. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM REPORTED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE SYSTEM WAS FOUND TO MEET SPECIFICATIONS; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING THE QUAD PHACOEMULSIFICATION PORTION OF A CATARACT PROCEDURE THE SYSTEM PRESSURE INCREASED AND THE PATIENT'S CAPSULE BROKE. THE WOUND WAS SUTURED. THE INTRAOCULAR LENS WAS NOT IMPLANTED. THE PATIENT WAS SENT FOR A RETINA EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437937 CENTURION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other