BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2944995 · Received February 4, 2013

    Report

    Report Number
    1119421-2013-00103
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 1, 2012
    Report Date
    January 5, 2013
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. CITATION: MU J, LI YZ, CHEN H. COMPARE THE TWO METHODS OF IMPROVING SPECTACLE INDEPENDENCE IN PATIENTS AFTER OPERATION ON VISUAL FUNCTION. GUOJI YANKE ZAZHI (INT EYE SCI) 2012; 12(12): 2335-2337. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, AN OPHTHALMOLOGIST REPORTED THE RESULTS OF A STUDY THAT COMPARED THE VISUAL FUNCTION IN PATIENTS WITH BILATERAL DIFFRACTIVE MULTIFOCAL INTRAOCULAR LENSES (IOLS) AND PATIENTS WITH MONOVISION IOLS. FOR THE TWO GROUPS, CONTRAST SENSITIVITY DECLINED COMPARED TO NORMAL STATE; HOWEVER, NO STATISTICAL SIGNIFICANCE WAS OBSERVED (P>0.05). STEREO VISION DAMAGE (STEREO VISION <60") WAS OBSERVED IN BOTH GROUPS. STEREO BLINDNESS WAS OBSERVED IN ONE CASE IN THE MULTIFOCAL GROUP AND SEVEN CASES IN THE MONOVISION GROUP. THE PATIENTS IN THE MULTIFOCAL IOL GROUP EXPERIENCED HALOS, GLARE, DOUBLE VISION AND TROUBLE WITH NIGHT VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT REPRESENTS THE MONOVISION GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47077 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH. LTD./HUNTINGTON SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other VISCOELASTIC