BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1025222 · Received April 4, 2008

    Report

    Report Number
    1119421-2008-00216
    Event Type
    Injury
    Date Received
    April 4, 2008
    Date of Event
    February 5, 2008
    Report Date
    March 7, 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
    OR, US
    Reporter Occupation
    OTHER

    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 INFORMATION WAS REQUESTED 03/07/2008, 03/12/2008 AND 04/01/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT AN INTRAOCULAR LENS (IOL) HAD TO BE EXCHANGED. THE LENS HAD A DAMAGED HAPTIC THAT WAS PREVENTING IT FROM CENTERING, AND THE PATIENT REPORTED EYE PAIN. THE PATIENT IS DOING "EXCELLENT" FOLLOWING THE EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD3 10745210

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention