BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 1343197 · Received March 12, 2009

    Report

    Report Number
    2028159-2009-00059
    Event Type
    Injury
    Date Received
    March 12, 2009
    Report Date
    February 10, 2009
    Manufacturer
    ALCON -IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE WILL BE RETURNING THE PHACO HANDPIECES FOR EVALUATION. 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.

    Description of Event or Problem · 1

    THE NURSE REPORTED A POSSIBLE ISSUE WITH THE PHACO HANDPIECES. THE NURSE REPORTED THAT PATIENTS ARE DEVELOPING RED EYE SYMPTOMS AFTER THEY STOP TAKING EYE DROPS FIVE TO SIX WEEKS AFTER SURGERY. ADDITIONAL INFORMATION RECEIVED STATED THE PATIENT SWABS WERE NEGATIVE, AND THE RED EYE IS PERSISTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQE ALCON -IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other