BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 8644187 · Received May 27, 2019

    Report

    Report Number
    1119421-2019-00758
    Event Type
    Malfunction
    Date Received
    May 27, 2019
    Date of Event
    April 22, 2019
    Report Date
    May 27, 2019
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A HEALTH AUTHORITY REPRESENTATIVE REPORTED THAT PREOPERATIVELY, AN INTRAOCULAR LENS (IOL) WAS NOTED TO BE SCRATCHED. A NEW LENS WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT HARM. THE REPORTER DID NOT PROVIDE ANY CONTACT INFORMATION; THEREFORE, FOLLOW UP WAS NOT ABLE TO BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437735 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON SN6AD1 12566858

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR