BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 3925430 · Received June 18, 2014

    Report

    Report Number
    1119421-2014-00472
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING SURGERY AN INTRAOCULAR LENS (IOL) JUMPED OUT OF THE CARTRIDGE AND TORE THE PT'S POSTERIOR CAPSULE. THE SURGEON PERFORMED AN ANTERIOR VITRECTOMY TO RETRIEVE THE IOL AND IMPLANTED AN IOL OF A DIFFERENT MODEL. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356747 ACRYSERT DELIVERY SYSTEM LENS GUIDE HQL ALCON RESEARCH, LTD./HUNTINGTON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention