BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX TRIFOCAL IOL

    MDR report key: 19849853 · Received July 29, 2024

    Report

    Report Number
    1119421-2024-01415
    Event Type
    Injury
    Date Received
    July 29, 2024
    Report Date
    November 4, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION PROVIDED IN B.5. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN H.3., H.6., AND H.11 NO SAMPLE WAS AVAILABLE TO RETURN. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE LITERATURE REPORT DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE ROOT CAUSE COULD NOT BE DETERMINED. THE FILE HAS BEEN OPENED FROM A LITERATURE REPORT: CLINICAL OUTCOMES IN EYES WITH DIFFRACTIVE CONTINUOUS DEPTH-OF-FOCUS INTRAOCULAR LENSES ENHANCED FOR NEAR VISION: COMPARISON WITH TRIFOCAL INTRAOCULAR LENSES. THE BINOCULAR VISUAL FUNCTIONS OF PATIENTS WITH CONTINUOUS DEPTH-OF-FOCUS IOL (INTRAOCULAR LENS) WERE COMPARABLE TO OR BETTER THAN THOSE OF PATIENTS WHO RECEIVED TRIFOCAL IOLS. ALTHOUGH THE GLARE AND HALO WERE LESS WITH THE TRIFOCAL LENS. THERE WERE NO SIGNIFICANT DIFFERENCES IN THE BDCVA (BEST CORRECTED VISUAL ACUITY) AND ALL-DISTANCE CONTRAST SENSITIVITY. AT THIS TIME, IT WAS UNCLEAR WHY SATISFACTION WITH NEAR VISION WAS HIGHER IN PATIENTS WITH THE CDF (CORRECTED DEPTH OF FOCUS) IOLS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    THE RESEARCH ARTICLE PUBLISHED WITH A PURPOSE TO EVALUATE THE VISUAL FUNCTIONS AND PATIENT SATISFACTION AFTER BILATERAL IMPLANTATION OF DIFFRACTIVE CONTINUOUS DEPTH-OF-FOCUS INTRAOCULAR LENS (CDF IOL) COMPARED WITH TRIFOCAL IOLS. THE STUDY WAS CONDUCTED USING CDF IOL (SYNERGY, J&J, GROUP S) AND TRIFOCAL IOL (ACRYSOF PANOPTIX, ALCON, GROUP P) WERE IMPLANTED BILATERALLY IN 30 PATIENTS EACH. THREE MONTHS POSTOPERATIVELY, BINOCULAR OUTCOMES OF UNCORRECTED (BUCVA) AND DISTANCE-CORRECTED (BDCVA) VISUAL ACUITIES AT DISTANCES OF 0.3, 0.4, 0.5, 0.7, AND 5 M WERE MEASURED. CONTRAST SENSITIVITIES WERE BINOCULARLY MEASURED USING CSV-1000 (2.5 M) AND PELLI-ROBSON CHARTS AT DISTANCES OF 0.4 AND 1 M. SYMPTOMS OF GLARE, HALO, STARBURST, AND WAXY VISION, AND SATISFACTION FOR NEAR, INTERMEDIATE, AND FAR VISIONS WERE ASSESSED WITH QUESTIONNAIRES. SYMPTOMS OF GLARE, HALO, STARBURST, AND WAXY VISION WERE ASSESSED USING A QUESTIONNAIRE, AND THE SEVERITY WAS GRADED ON A 5-POINT SCALE: NOT AT ALL, SLIGHT: MODERATE, AND VERY: EXTREME (IMPAIRING DAILY LIFE). DIFFERENCES BETWEEN THE TWO GROUPS WERE EXAMINED. THE STUDY RESULTS STATED TWENTY-SEVEN PATIENTS EACH COMPLETED THE FOLLOW-UP. THE MEAN AGE OF THE GROUP S WAS LOWER THAN THAT OF THE GROUP P (P < 0.001). THE BUCVA AT 0.4 M WAS BETTER IN THE S GROUP, WHILE THE MEAN MANIFEST REFRACTION OF THE P GROUP SHOWED A SIGNIFICANT HYPEROPIC SHIFT (P < 0.001). BDCVA WAS SIGNIFICANTLY BETTER IN THE S GROUP. THE CONTRAST SENSITIVITY RESULTS AT THREE DISTANCES SHOWED NO DISCERNIBLE DIFFERENCES. ALTHOUGH MORE PATIENTS IN THE S GROUP REPORTED SIGNIFICANT GLARE AND HALO, THEIR SATISFACTION WITH NEAR VISION WAS HIGHER. THE STUDY WAS CONCLUDED AS THE BINOCULAR VISUAL FUNCTION OF PATIENTS WITH CDF IOLS WAS COMPARABLE TO OR BETTER THAN THAT OF PATIENTS WITH TRIFOCAL IOLS. THE PATIENTS WERE SATISFIED WITH NEAR VISION, DESPITE THE ENHANCED GLARE AND HALO. UNDERSTANDING THE DIFFERENCES BETWEEN THE TWO TYPES OF PRESBYOPIA-CORRECTING IOLS IS IMPORTANT TO ENSURE PATIENT SATISFACTION. THIS FILE BELONGS TO 50 EYES OF 25 PATIENTS WHO GOT IMPLANTED WITH TFNT00/TFNT30/TFNT40/TFNT50, WHERE HALO WAS OBSERVED SLIGHTLY IN 6, MODERATELY IN 8, VERY SEVERELY IN 8 AND EXTREME SEVERELY IN 3 PATIENTS. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 2 OF 4. NOMURA Y ET AL. CLINICAL OUTCOMES IN EYES WITH DIFFRACTIVE CONTINUOUS DEPTH-OF-FOCUS INTRAOCULAR LENSES ENHANCED FOR NEAR VISION: COMPARISON WITH TRIFOCAL INTRAOCULAR LENSES. BMC OPHTHALMOL. 2023;23:475.

    Description of Event or Problem · 0

    THIS FILE BELONGS TO PATIENTS IMPLANTED WITH COMPANY NON-TORIC IOL (TFNT00) WHERE HALO WAS OBSERVED VERY SEVERELY IN 8 PATIENTS AND EXTREME SEVERELY IN 3 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897257 ACRYSOF IQ PANOPTIX TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON NI ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL.