BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 6519176 · Received April 25, 2017

    Report

    Report Number
    1119421-2017-00559
    Event Type
    Injury
    Date Received
    April 25, 2017
    Report Date
    April 25, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: 2016-103688.

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED A PATIENT WITH POOR VISION AFTER HAVING INTRAOCULAR LENS (IOL) IMPLANT. THE LENS WAS EXCHANGED. THE SURGEON REPORTS THE PATIENT'S VISION IS BETTER FOLLOWING THE EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299597 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LTD. - HUNTINGTON SN6AD1 12347421

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention