BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL

    MDR report key: 21948902 · Received May 2, 2025

    Report

    Report Number
    1119421-2025-01264
    Event Type
    Injury
    Date Received
    May 2, 2025
    Report Date
    August 21, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652389365
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN D.9.,H.3.,H.6 AND H.11. THE LENS WAS RETURNED FOR EVALUATION. SOLUTION IS DRIED ON THE LENS. THE LENS IS CUT IN HALF, TYPICAL OF INSERTION AND REMOVAL FROM THE EYE. MARKS AND CRACKS ARE OBSERVED ON BOTH SIDES OF THE OPTIC THAT ARE SIMILAR TO THOSE LEFT BY A SURGICAL INSTRUMENT USED TO GRASP THE LENS. A POWER AND RESOLUTION INSPECTION COULD NOT BE CONDUCTED DUE TO EXTENSIVE DAMAGE. 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 FOR THE REPORTED COMPLAINT. EACH LENS IS SUBJECTED TO A 100 PERCENT ASSESSMENT OF THE POWER (SPHERICAL AND CYLINDER) AND OPTICAL RESOLUTION DURING THE MANUFACTURING PROCESS IN ORDER TO DETERMINE ACCEPTABILITY PER THE LENS MODEL AND DIOPTER. A POWER AND RESOLUTION INSPECTION COULD NOT BE CONDUCTED DUE TO EXTENSIVE DAMAGE. INFORMATION WAS PROVIDED THAT THE COMPANY LENS, 17.0 DIOPTER (ADD POWER PLUS 2.2/PLUS 3.2) LENS WAS REPLACED WITH AN UNSPECIFIED LENS MODEL. ADDITIONAL INFORMANT WAS PROVIDED THAT THE INITIAL LENS WAS IMPLANTED ON (B)(6) 2021 AND EXPLANTED ON (B)(6) 2021. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT (TFNT30-60) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P040020). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DISCOMFORT. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 10 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE PATIENT ONLY EXPERIENCED DISCOMFORT AND NO VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657033 ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT20 15006852 00380652389365

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention