BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2963485 · Received February 13, 2013

    Report

    Report Number
    1119421-2013-00127
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 1, 2012
    Report Date
    January 14, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER 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 REPORTER TO PROPERLY COMPLETE AN INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY PHONE, EMAIL, FAX AND MAIL ON (B)(4) 2013. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXCHANGED TO A MONOFOCAL LENS ONE WEEK FOLLOWING THE INITIAL IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63784 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention