BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF RESTORE

    MDR report key: 1062043 · Received June 13, 2008

    Report

    Report Number
    1119421-2008-00438
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 15, 2008
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED 05/16/2008 BY MAIL. A COMPLETED QUESTIONNAIRE WAS REC'D.

    Description of Event or Problem · 1

    A REGISTERED NURSE REPORTS THAT AN INTRAOCULAR LENS WAS SCRATCHED. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTORE INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. SN6AD3 10758756

    Patients

    Seq Age Sex Outcome Treatment
    1