BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX

    MDR report key: 22236357 · Received June 17, 2025

    Report

    Report Number
    MW5171597
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    December 8, 2020
    Report Date
    June 7, 2025
    Manufacturer
    ALCON / ALCON RESEARCH, LLC
    Product Code
    MFK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WOULD LIKE TO REPORT A PROBLEM FOLLOWING CATARACT SURGERY. DOCTOR PERFORMED CATARACT SURGERY WITH ALCON MULTI FOCAL LENS IN BOTH EYES. THE LENS IN THE LEFT EYE HAS NEVER WORKED. THE NEW LENS HAS CAUSED DOUBLE VISION AND BLURRED VISION IN THE LEFT EYE. I REPORTED THIS TO THE DOCTOR AND HE SAID THAT THE NEW LENS WRINKLED WHEN IT WAS INSERTED. HE PERFORMED ANOTHER SURGERY TO CORRECT THE WRINKLE. THAT DID NOT CORRECT THE PROBLEM. I HAVE SEEN TWO OTHER EYE DOCTORS, AND THEY AGREE THAT THE LENS IS NOT WORKING BUT I HAVE NOT HEARD WHY THE LENS DOES NOT WORK. THERE IS SPECULATION AS TO WHY THE BLURRED AND DOUBLE VISION. PROBLEM COULD BE THAT THE WRONG LENS WAS USED IN THE LEFT EYE; DOCTOR¿S ASSISTANT COULD HAVE HANDED HIM THE WRONG LENS, LENS MAY HAVE NOT BEEN CORRECTLY MARKED IN THE PACKAGE BUT BOTTOM LINE THE VISION IS NOT CORRECT IN THE LEFT EYE. THE DOCTOR THAT I AM SEEING NOW PRESCRIBED A CONTACT LENS THAT MUST BE WORN DAILY. THIS IS A CORRECTION LENS. BUT THE CATARACT SURGERY ON (B)(6) 2020 SHOULD HAVE CORRECTED THE VISION AND I SHOULD NOT HAVE TO BUY CONTACT LENS FOREVER TO CORRECT THE VISION THAT SHOULD HAVE BEEN CORRECTED WITH THE CATARACT SURGERY. THE CATARACT SURGERY AND THE WRINKLED LENS SURGERY WERE PAID PARTIALLY OUT OF (B)(6) AND MOSTLY OUT OF POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28523 ACRYSOF IQ PANOPTIX LENS, MULTIFOCAL INTRAOCULAR MFK ALCON / ALCON RESEARCH, LLC SN. 12725040 069 NOT SHOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male 81MG ASPIRIN.| ATORVASTATIN.| DORZOLAMIDE.| LUMIGAN.| METOPROLOL.| MULTI VITAMIN.| STOOL SOFTENER.