BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR IOL

    MDR report key: 8697046 · Received June 13, 2019

    Report

    Report Number
    1119421-2019-00898
    Event Type
    Injury
    Date Received
    June 13, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGY LIAISON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS POSSIBLY EXPLANTED. ADDITIONAL INFORMATION WAS REPORTED THAT THE LENS WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491078 ACRYSOF RESTOR IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention