BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTREPID AUTOSERT IOL HANDPIECE

    MDR report key: 6376355 · Received March 3, 2017

    Report

    Report Number
    2028159-2017-00958
    Event Type
    Injury
    Date Received
    March 3, 2017
    Date of Event
    February 21, 2017
    Report Date
    June 14, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQR
    PMA / PMN Number
    K112425
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THIS CUSTOMER. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMERS REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. THE SYSTEM WAS MANUFACTURED ON NOVEMBER 6, 2015. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT WHILE IMPLANTING AN INTRAOCULAR LENS (IOL) THE PLUNGER OF THE INJECTOR OVERRODE THE LENS AND IT BROKE WHILE ENTERING THE CAPSULAR SAC. THE SURGEON REMOVED THE IOL AND USED AN ALTERNATE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159077 INTREPID AUTOSERT IOL HANDPIECE APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED HQR ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention