BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1051082 · Received May 22, 2008

    Report

    Report Number
    1119421-2008-00356
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 22, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO WAS REQUESTED 04/23/2008 AND 04/30/2008 BY PHONE, FAX AND MAIL. A COMPLETE QUESTIONNAIRE WAS RECEIVED FROM THE SURGEON.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO SMUDGE NOTED IN THE CENTER OF THE LENS. IN A FOLLOW-UP, THE SURGEON REPORTS THE OUTCOME OF EVENT FOR THE PT AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention