BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 3772417 · Received December 18, 2013

    Report

    Report Number
    1119421-2013-01261
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    January 1, 2013
    Report Date
    November 25, 2013
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFR DOCUMENTATION. THE PRODUCT WAS NOT RETURNED AND NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. BISSEN-MIYAJIMA H, MINAMI K, YOSHINO M, TAIRA Y. SURFACE LIGHT SCATTERING AND VISUAL FUNCTION OF DIFFRACTIVE MULTIFOCAL HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES 6 YEARS AFTER IMPLANTATION. J CATARACT REFRACT SURG 2013; 39:1729-1733. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE REPORT, THE AUTHORS EVALUATED THE SURFACE LIGHT SCATTERING ASSOCIATED WITH DIFFRACTIVE MULTIFOCAL INTRAOCULAR LENSES (IOL) AND VISUAL FUNCTION. SIXTY FOUR PATIENTS RECEIVED A MULTIFOCAL OR MONOFOCAL IOL BETWEEN THE STUDY PERIOD OF SEPTEMBER 2003 AND MARCH 2004. EYES THAT HAD A FOLLOW UP LONGER THAN SIX YEARS WERE DIVIDED INTO TWO GROUPS. THE STUDY GROUP COMPRISED TEN PATIENTS (20 EYES) WHO RECEIVED A DIFFRACTIVE MULTIFOCAL IOL, AND THE CONTROL GROUP COMPRISED EIGHT PATIENTS (16 EYES) WHO RECEIVED A DIFFRACTIVE MONOFOCAL IOL. SIX YEARS POSTOPERATIVELY, THE INTENSITY OF THE SURFACE LIGHT SCATTERING WAS MEASURED USING A (B)(4) CAMERA BASED ANTERIOR SEGMENT ANALYZER. THE CORRECTED DISTANCE AND NEAR VISUAL ACUITIES AND CONTRAST SENSITIVITY WERE ADDRESSED. BETWEEN YEARS ONE THRU SIX POSTOPERATIVELY, THERE WERE NO SIGNIFICANT CORRELATIONS BETWEEN SURFACE LIGHT SCATTERING AND CHANGES IN CORRECTED VISUAL ACUITIES AT DISTANCE OR NEAR. ALTHOUGH SURFACE LIGHT SCATTERING INCREASES WITH YEARS, MULTIFOCAL IOL'S PROVIDE GOOD VISUAL ACUITIES IN THE LONG TERM. SIX YEARS POSTOPERATIVELY, THE VISUAL FUNCTION WITH A DIFFRACTIVE MULTIFOCAL IOL WAS COMPARABLE TO A MONOFOCAL IOL. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE MULTIFOCAL LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664017 ACRYSOF INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD. SA60AT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1