BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYS

    MDR report key: 3900042 · Received May 27, 2014

    Report

    Report Number
    2028159-2014-00984
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A SERVICE VISIT HAS BEEN PERFORMED AND THE 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. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT, DURING SURGERY, WHILE USING THE PHACOEMULSIFIER, THE POSTERIOR CAPSULE WAS INEXPLICABLY BROKEN FOR THREE PATIENTS. AFTER THIS PT, THE SURGEON DECIDED TO EXCHANGE THE SYSTEM. THE REST OF THE SESSION CONTINUED WITHOUT PROBLEMS. THIS PT WAS THE SIXTH OF TWELVE PATIENTS BEING OPERATED THAT DAY. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THIS IS ONE OF THREE MEDICAL DEVICE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311977 CENTURION VISION SYS PHACOFRAGMENTATION SYS HQC ALCON RESEARCH, LTD. / HUNTINGTON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other