BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 4702702 · Received April 17, 2015

    Report

    Report Number
    1119421-2015-05153
    Event Type
    Injury
    Date Received
    April 17, 2015
    Date of Event
    October 16, 2014
    Report Date
    April 17, 2015
    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
    PK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEVICE REMAINS IMPLANTED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. INITIAL REPORTER: ZIP CODE IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A PATIENT REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HE CANNOT SEE ITEMS UP CLOSE. THE PATIENT WAS TOLD HE HAD POSTERIOR CAPSULAR OPACIFICATION (PCO). THE SURGEON PERFORMED A POSTERIOR CAPSULOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256583 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LTD. - HUNTINGTON SN6AD1 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention