BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 3931204 · Received June 10, 2014

    Report

    Report Number
    3931204
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 29, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN NOTICED GLISTENINGS IN THE FOLLOW UP VISIT ON LENS IMPLANTS; PATIENT HAS GOOD SNELLEN VISION BUT THE GLISTENINGS COULD AFFECT HIS CONTRAST SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342508 ACRYSOF ARTIFICIAL INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. SN60WF *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR