BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX TRIFOCAL IOL

    MDR report key: 17069650 · Received June 6, 2023

    Report

    Report Number
    1119421-2023-01033
    Event Type
    Injury
    Date Received
    June 6, 2023
    Report Date
    July 24, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652357708
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ASSOCIATED PRODUCTS WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THE POWER AND RESOLUTION OF EACH LENS IS 100% EVALUATED DURING THE MANUFACTURING PROCESS TO DETERMINE ACCEPTABILITY PER MODEL AND DIOPTER. THE FILE WILL BE REOPENED IF ADDITIONAL INFORMATION IS PROVIDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT SUFFERED CHAINING (WHICH FELT LIKE A SENSATION OF A CONTACT LENS COMING OUT OF THE EYE), BLURRY/FOGGY VISION DISRUPTING ALL ACTIVITIES (NEAR/FAR/IN-BETWEEN). IT APPEARED AS THOUGH THE LENS WAS GROWING INSIDE THE EYE. THE PATIENT'S VISION WAS GREAT UP CLOSE AND HAD GOTTEN WORSE FOLLOWING THE IMPLANT. THE PATIENT HAD NO TROUBLE SEWING OR CROCHETING BEFORE THE IMPLANTATION, BUT AFTERWARD, NEEDED GLASSES TO CARRY ON WITH EVERYDAY ACTIVITIES. THE INTERMEDIATE. DISTANCE AND FAR VISION WAS NOT SHARP. THE IMPLANTED LENS DID NOT CORRECT THE DULL APPEARANCE. PATIENT WAS NOT SATISFIED WITH THE RESULTS. THE DOCTOR CONCLUDED FROM THE MEDICAL PROGNOSIS THAT THE LENS WAS IN PLACE AND ADVISED WAITING 6-8 MONTHS TO SEE IF SYMPTOMS IMPROVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745227 ACRYSOF IQ PANOPTIX TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT00 15431991 00380652357708

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other