BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1033352 · Received April 24, 2008

    Report

    Report Number
    1119421-2008-00270
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 25, 2008
    Manufacturer
    ALCON MANUFACTURING, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PROD HISTORY RECORD REVIEW INDICATED THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT #. ADD'L INFO WAS REQUESTED 04/09/2008 AND 04/10/2008 BY PHONE FAX AND MAIL. ADD'L INFO WAS REC'D BY PHONE ON 04/15/2008. THE SURGEON IS UNWILLING TO COMPLETE THE PT QUESTIONNAIRE. THIS REPORT WAS MAILED TO FDA ON: 04/24/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS HE EXCHANGED AN INTRAOCULAR LENS BECAUSE THE HAPTICS WERE STUCK TO THE OPTIC. IN A F/U, THE SURGEON REPORTS THAT THE CAPSULE BROKE DURING THE PROCEDURE AND THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD. / HUNTINGTON SN60WF 10756501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention