BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 3127418 · Received May 21, 2013

    Report

    Report Number
    1119421-2013-00546
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    January 1, 2007
    Report Date
    April 23, 2013
    Manufacturer
    ALCON RESEARCH LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H3, H6: 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 FOR FURTHER INVESTIGATION. RONBECK, MARGRETHE; MEHNDIG, ANDERS; TAUBE, MIKEALA; KOIVULA, ANNEMARI AND KUGELBERG, MARIA. COMPARISON OF GLISTENINGS IN INTRAOCULAR LENSES WITH THREE DIFFERENT MATERIALS: 12-YEAR-FOLLOW-UP. ACTA OPTHALMOLOGICA; 2013; 91: 66-70. (B)(4).

    Description of Event or Problem · 1

    THE AUTHOR OF A LITERATURE ARTICLE REPORTED THE INCIDENCE OF GLISTENINGS FOUND IN A STUDY THAT COMPARED THREE DIFFERENT INTRAOCULAR LENS (IOL) MATERIALS OVER TWELVE YEARS. THE PTS WERE RANDOMIZED TO IMPLANTATION WITH ONE OF THE THREE IOL'S: HEPARIN-SURFACE-MODIFIED PMMA IOL, A FOLDABLE SILICONE LENS, OR A FOLDABLE HYDROPHOBIC ACRYLIC LENS. THE 46 PTS IN THIS PROSPECTIVE STUDY UNDERWENT UNCOMPLICATED PHACOEMULSIFICATION FROM MAY 1995 TO MARCH 1998; ONE EYE OF EACH PT WAS INCLUDED. GLISTENINGS DEVELOPED IN ALL THREE IOL TYPES. ELEVEN OF THE 46 EYES WERE IN THE PMMA IOL GROUP, 16 EYES WERE IN THE SILICONE IOL GROUP, AND 19 EYES WERE IN THE HYDROPHOBIC ACRYLIC IOL GROUP. THE MEDIAN POSTOPERATIVE FOLLOW-UP TIME WAS 146 MONTHS (~12 YEARS). THE HYDROPHOBIC ACRYLIC IOL HAD SIGNIFICANTLY MORE LENS GLISTENINGS THAN THE SILICONE AND THE PMMA IOL'S. THE IOL POWER DID NOT AFFECT THE DEGREE OF LENS GLISTENINGS. ACCORDING TO THE AUTHOR, THE CURRENT STUDY WAS NOT TO INVESTIGATE WHETHER LENS GLISTENINGS HAVE AN EFFECT ON POSTOPERATIVE VISUAL FUNCTION; THEREFORE, NO VISUAL ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225514 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD/HUNTINGTON MA60BM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1