BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2924851 · Received January 17, 2013

    Report

    Report Number
    1119421-2013-00027
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    May 1, 2009
    Report Date
    December 17, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE VIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE ROOT CAUSE COULD NOT BE DETERMINED, NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ZELDOVICH, A. TREATMENT OF NEGATIVE DYSPHOTOPSIA WITH UNIQUE SULCUS LENS, CLINICAL & EXPERIMENTAL OPHTHALMOLOGY, 2012; 40: 829-830. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, A SURGEON REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, A PT EXPERIENCED NEGATIVE DYSPHOTOPSIA IN BOTH EYES. THE PT ALSO FELT HER PERIPHERAL VISION WAS CONSTRICTED BY BILATERAL DARK TEMPORAL CRESCENTS. TWO YEARS FOLLOWING THE INITIAL SURGERIES, A SULCUS LENS WAS INJECTED INTO THE PATIENT'S LEFT EYE. HER SYMPTOMS OF NEGATIVE DYSPHOTOPSIA DISAPPEARED FROM THE FIRST PREOPERATIVE VISIT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26244 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention COMBINATION LATANOPROST/TIMOLOL| DATE: UNK