BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1155962 · Received September 5, 2008

    Report

    Report Number
    1119421-2008-00663
    Event Type
    Other
    Date Received
    September 5, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 7, 2008
    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
    NJ, 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. ADDITIONAL INFO WAS REQUESTED ON 08/11/2008, 08/25/2008, AND 09/02/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTS A PT WITH AN UNEXPECTED POSTOPERATIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) SURGERY. ADDITIONAL 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 Other