BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2470480 · Received February 24, 2012

    Report

    Report Number
    1119421-2012-00244
    Event Type
    Injury
    Date Received
    February 24, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 26, 2012
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 02/02/2012 AND 02/21/2012 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED IN A FOLLOW UP PHONE CALL ON 02/21/2012. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN INTRAOCULAR LENS (IOL) WAS EXCHANGED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON'S RECEPTIONIST WHO REPORTED THE IOL WAS EXCHANGED DUE TO A CRACK BEING NOTED IN THE LENS ON THE FIRST POSTOPERATIVE DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12030129

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention