BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2871539 · Received December 6, 2012

    Report

    Report Number
    1119421-2012-01514
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    December 1, 2011
    Report Date
    November 6, 2012
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    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. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE WERE NO OTHER COMPLAINTS REPORTED IN THE LOT. ADDITIONAL INFO HAS BEEN REQUESTED. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A PT WAS EXPERIENCING DYSPHOTOPSIA FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON HAS TRIED SEVERAL DIFFERENT TYPES OF TREATMENTS BUT NONE HAVE BEEN SUCCESSFUL, AT THIS TIME. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 11057822

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention