BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 3006124 · Received March 6, 2013

    Report

    Report Number
    1119421-2013-00246
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 1, 2011
    Report Date
    February 6, 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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDED A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ADD'L INFO HAS BEEN REQUESTED. CITATION: COLIN J, PRAUD D, TOUBOUL D, SCHWEITZER C. (2012). INCIDENCE OF GLISTENINGS WITH THE LATEST GENERATION OF YELLOW-TINTED HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES. J CATARACT REFRACT SURG. 2012; 38:1140-1146. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, GLISTENINGS OCCURRED IN 96 EYES. GLISTENING WITH GRADE 1 SEVERITY (MODERATE) WAS OBSERVED IN 45 EYES AND GLISTENINGS WITH GRADE 2 SEVERITY (DENSE) WAS OBSERVED IN 51 EYES. THE ARTICLE INDICATED THAT GLISTENINGS SHOWED NO CLEAR EFFECT ON VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95627 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 MONARCH II DELIVERY SYSTEM - SURGERIES BETWEEN| (B)(6) 2011 AND (B)(6) 2011