BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 6114571 · Received November 18, 2016

    Report

    Report Number
    1119421-2016-01619
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    September 26, 2016
    Report Date
    July 6, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE USE OF A QUALIFIED CARTRIDGE WITH A HANDPIECE. CARTRIDGE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. TWO VISCOELASTICS WERE INDICATED, ONLY ONE IS QUALIFIED FOR THIS LENS/CARTRIDGE COMBINATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A SURGICAL COORDINATOR REPORTED A PLANNED EXCHANGED FOR A PATIENT WHO HAS HAD SEVERE HALOS/GLARE AT NIGHT AFTER HAVING BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS. SHE HAS HAD A COMBO OF THE +2.5/+3.0 IMPLANTS, AND THEY WILL BE EXCHANGING THE +3.0 FIRST. THIS FILE IS FOR THE +3.0 LENS (UNKNOWN EYE).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT IS UNABLE TO DRIVE AT NIGHT DUE TO THE SEVERE AURAS/GLARE RELATED TO THE IOLS. THIS FILE IS FOR THE PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764441 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LTD. - HUNTINGTON SN6AD1 12279565

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other