BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3102364 · Received April 30, 2013

    Report

    Report Number
    1119421-2013-00461
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    January 1, 2012
    Report Date
    March 8, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED GLISTENINGS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE BILATERALLY IMPLANTED PATIENT'S LEFT EYE. THE REPORT FOR THE UNKNOWN PATIENTS HAS PREVIOUSLY BEEN REPORTED ON MANUFACTURER REPORT NUMBER 1119421-2013-00350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187865 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12089282

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK