BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL

    MDR report key: 21264644 · Received January 29, 2025

    Report

    Report Number
    1119421-2025-00243
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    November 13, 2024
    Report Date
    April 2, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MJP
    UDI-DI
    00380652457309
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6. AND H.11. THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED, AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ACCOUNT INDICATED THE USE OF A QUALIFIED CARTRIDGE AND HANDPIECE WITH A NON-QUALIFIED VISCOELASTIC. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE ACCOUNT INDICATED THE PRODUCT WAS NOT AVAILABLE TO EVALUATE. EACH LENS IS SUBJECTED TO A 100 PERCENT ASSESSMENT OF THE POWER AND OPTICAL RESOLUTION DURING THE MANUFACTURING PROCESS IN ORDER TO DETERMINE ACCEPTABILITY PER THE LENS MODEL AND DIOPTER. INFORMATION WAS PROVIDED THAT THE MULTIFOCAL COMPANY (1.50CYL), 16.0 DIOPTER (ADD POWER +2.2 OR +3.2) LENS WAS REPLACED WITH A NON-COMPANY, 14.0 DIOPTER, MONOFOCAL LENS. DUE TO THE EXCHANGE OF A MULTIFOCAL LENS TO A 2.0 LOWER DIOPTER, MONOFOCAL LENS, THIS MAY SUGGEST THAT THE REPLACEMENT LENS MODEL WAS AN IMPROVED CHOICE FOR THE PATIENT'S VISION NEEDS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATING THAT THE PATIENT EXPERIENCED TEMPORAL CRESCENT-SHAPED NEGATIVE DYSPHOTOPSIA, NOTICED MOST OF THE TIME AND DID NOT IMPROVE WITH ADDITIONAL HEALING. IN THE SURGEON'S OPINION, THE IOL DESIGN (EDGE OF THE IOL) CONTRIBUTED TO THE EVENT. THE LENS WAS EXCHANGED WITH A NON-COMPANY IOL AFTER THE INITIAL IMPLANT PROCEDURE. THERE WAS NO PATIENT HARM. THE PATIENT'S ISSUE WAS RESOLVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR RIGHT EYE.

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED GLARE AND VISUAL DISTORTION, HALOS AND NEGATIVE DYSPHOTOPSIA. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANTATION WAS MECHANICAL COMPLICATION WITH PROSTHETIC LENS, NEGATIVE DYSPHOTOPSIA SIGNIFICANT GLARE AND HALOS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953550 CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LLC - HUNTINGTON CCWTT3 15744718 00380652457309

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR| MONARCH II LOADING FORCEPS| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D| TOTALVISC OVD