BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF RESTOR

    MDR report key: 4152494 · Received October 6, 2014

    Report

    Report Number
    1119421-2014-00764
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ALCON -IRVINE TECH CTR
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED. THE LENS REMAINS IMPLANTED IN THE PT'S EYE. PRODUCT HISTORY AND BATH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS TO GATHER ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED, GLISTENINGS WERE OBSERVED. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622187 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON -IRVINE TECH CTR SN6AD1 12032833

    Patients

    Seq Age Sex Outcome Treatment
    1