BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2945058 · Received February 4, 2013

    Report

    Report Number
    1119421-2013-00096
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 1, 2010
    Report Date
    January 5, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    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. HONG-SHENG B, JIAN-FENG US, DONG-MEI L, WAN-TING C, XIAO-FENG X (2010) EVALUATING VISUAL QUALITY OF AN ASPHERIC MULTIFOCAL INTRAOCULAR LENS. NATIONAL MEDICAL JOURNAL OF CHINA 90(7); 447-50. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, THE AUTHORS PRESENTED THE RESULTS OF A RETROSPECTIVE STUDY COMPARING THE VISUAL QUALITY OF PATIENTS IMPLANTED WITH TWO DIFFERENT MULTIFOCAL LENSES. THE PATIENTS WERE SEEN AT THREE MONTHS POSTOPERATIVELY WHERE UNCORRECTED AND BEST CORRECTED DISTANCE AND INTERMEDIATE VISUAL ACUITY, THE FOCUS DEPTH, HIGHER ORDER ABERRATION, CONTRAST SENSITIVITY AND GLARE SENSITIVITY WERE MEASURED IN BOTH THE TEST AND CONTROL GROUPS. PATIENTS WERE ORALLY ADMINISTERED A VISUAL FUNCTION QUESTIONNAIRE INCLUDING QUESTIONS ABOUT GLARE, HALOS, AND OTHER VISUAL DISCOMFORT. WHEN COMPARING THE BEST CORRECTED NEAR, FAR AND INTERMEDIATE VISUAL ACUITY BETWEEN THE TWO GROUPS, THE RESULTS WERE THE SAME. THE CONTRAST SENSITIVITY AND GLARE SENSITIVITY IN ALL FREQUENCY "SECT" OF GROUP TEST HAS BEEN MORE OBVIOUSLY IMPROVED POSTOPERATIVELY IN THE TEST GROUP THAN THE CONTROL GROUP. BOTH GROUPS HAD NO SERIOUS GLARE. THREE EYES FELT DISCOMFORT OF HALOS IN THE CONTROL GROUP COMPARED TO ONE EYE IN TEST GROUP. THE CONCLUSION DRAWN BY THE AUTHORS WAS THAT THE MULTIFOCAL LENS FOR THE TEST GROUP HAD NEGATIVE SPHERICAL ABERRATION BY AN SPHERICAL DESIGN IN THE FRONT SURFACE, WHICH MADE IT COUNTERACT THE POSITIVE SPHERICAL ABERRATION OF THE CORNEA. CONSEQUENTLY THE LENS USED OR THE TEST GROUP GAVE GOOD HIGH-CONTRAST VISUAL ACUITY FOR DISTANCE, NEAR AND INTERMEDIATE VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46065 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SN60D3 (CONTROL GROUP)| SN6AD3 (TEST GROUP)