BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1202838 · Received October 17, 2008

    Report

    Report Number
    1119421-2008-00814
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO HAS BEEN REQUESTED. THIS REPORT WAS MAILED TO FDA ON: 10/17/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT, DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE OPTIC OF THE IOL WAS FOUND TO HAVE A MARK ON IT. DURING THE PROCEDURE, THE IOL BECAME DECENTERED AND THE CAPSULAR BAG TORE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention