BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 8506797 · Received April 11, 2019

    Report

    Report Number
    1119421-2019-00460
    Event Type
    Injury
    Date Received
    April 11, 2019
    Report Date
    April 11, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED SEVERAL CASES OF TOXIC ANTERIOR SEGMENT SYNDROME/INFLAMMATION/ENDOPHTHALMITIS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES DATING BACK TO LATE 2017. THE REPORTER DID NOT SPECIFY WHICH ADVERSE EVENT MENTIONED WAS RELATED TO THIS SPECIFIC CASE. ADDITIONAL INFORMATION WAS PROVIDED INDICATING A NEGATIVE CULTURE RESULT FOR THIS SPECIFIC CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300431 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON SV25T0 12507426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other