BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF ASPHERIC UV ABSORBING IOL

    MDR report key: 16311961 · Received February 6, 2023

    Report

    Report Number
    MW5114727
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    January 18, 2022
    Report Date
    February 2, 2023
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    HQL
    UDI-DI
    00380652332705
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD CATARACT SURGERY IN BOTH EYES. THE SAME IMPLANT WAS USED IN BOTH EYES. EVERY SINCE, I HAVE HAD NEW GLARE PROBLEMS, STARBURST PATTERNS AROUND LIGHTS AT NIGHT, AND GHOSTING, MAKING IT HARD TO READ. I HAVE COMPLAINED TO THE SURGEON'S OFFICE, ONLY TO BE REFERRED TO A RETINAL SPECIALIST. THAT PROVED TO BE A WASTE OF TIME AS THEY FOUND NOTHING WRONG WITH MY RETINA. THE DOCTOR DID SAY HE SAW A REFLECTION IN MY CORNEA WHICH IS SOMETHING NEW. ALL ATTEMPTS, EVEN LETTERS, HAVE BEEN IGNORED WITH NO CONTACT FROM THE SURGEON. I THINK THESE PROBLEMS ARE A DIRECT RESULT OF THE IMPLANT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115948 ACRYSOF ASPHERIC UV ABSORBING IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC SA60WF 00380652332705
    115949 ACRYSOF ASPHERIC UV ABSORBING IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC SA60WF 00380652332705

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other ALPHAGAN| ARED VITAMIN| GINKO BOLBA| LORSORTAN| MULTI-VITAMIN| RESTAYSIS| TUMERIC| VITAMIN C