BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 3711465 · Received January 13, 2014

    Report

    Report Number
    1119421-2014-00022
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Report Date
    December 16, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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 INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. ADD'L INFO HAS BEEN REQUESTED. CITATION: LEYDOLT C, KRIECHBAUM K, SCHRIEFL S, PACHALA M, MENAPACE R. POSTERIOR CAPSULE OPACIFICATION AND NEODYMIUM: YAG RATES WITH 2 SINGLE-PIECE HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES: THREE-YEAR RESULTS. J CATARACT REFRACT SURG 2013; 39: 1886-1892. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE THE INVESTIGATORS REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, FOUR PATIENT PRESENTED WITH DECENTRATION OF THE IOL. THE STUDY EVALUATED 54 PATIENTS (108 EYES). ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34107 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SA60AT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK