BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 8523992 · Received April 17, 2019

    Report

    Report Number
    1119421-2019-00486
    Event Type
    Injury
    Date Received
    April 17, 2019
    Report Date
    June 13, 2019
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    . THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE CUSTOMER INDICATES AN UNSPECIFIED COMPANY CARTRIDGE WAS USED. A NON-COMPANY HANDPIECE AND VISCOELASTIC PRODUCT WERE INDICTED. THESE PRODUCTS HAVE NOT BE QUALIFIED FOR USE WITH THE QUALIFIED IOL/COMPANY COMBINATIONS FOR THIS LENS. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED EVENTS. THE LENS REMAINS IMPLANTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE EVENT OCCURRED SIX (6) AND A HALF WEEKS AFTER SURGERY IN THE RIGHT EYE. THE PATIENT NEEDED A PARABULBAR INJECTION FOR TREATMENT. THE SYMPTOMS ARE ONGOING AND BEING MONITORED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED THAT THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THEY HAVE HAD THREE (3) CASES OF THE PATIENT EXPERIENCING IRITIS. THIS IS FOR CASE THREE (3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315639 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON SV25T0 12515859

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DUCKWORTH & KENT HANDPIECE INJECTOR| HYPROMEL 2.5%| MONARCH CARTRIDGE