BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR IOL

    MDR report key: 4892517 · Received July 6, 2015

    Report

    Report Number
    1119421-2015-05757
    Event Type
    Injury
    Date Received
    July 6, 2015
    Report Date
    July 6, 2015
    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
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED MULTIPLE PATIENTS WITH COMPLAINTS OF INADEQUATE READING VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES. THE PATIENTS ALSO COMPLAINED OF ABERRATIONSIN VISION WHILE DRIVING AT NIGHT. THE DOCTOR REPORTED THAT THE BENEFITS OF CORRECTIVE LENSES IS RESTRICTED DUE TO THE OPTICS PASSING THROUGH THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435475 ACRYSOF RESTOR IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LTD. - HUNTINGTON ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other