BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX TRIFOCAL IOL

    MDR report key: 19861480 · Received July 30, 2024

    Report

    Report Number
    1119421-2024-01444
    Event Type
    Injury
    Date Received
    July 30, 2024
    Report Date
    November 7, 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
    HK
    Reporter Occupation
    PHYSICIAN
    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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS 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 OUTCOME OF A QUADRIFOCAL (TRIFOCAL) INTRAOCULAR LENS IN CHINESE PATIENTS: PROSPECTIVE, OBSERVATIONAL CASE SERIES. OUR STUDY REVEALED AN OVERALL SATISFACTORY VISUAL OUTCOME AND SUBJECTIVE EXPERIENCE IN PATIENTS WITH BILATERAL COMPANY TRIFOCAL IOL IMPLANTATION. IMPLANTATION OF THE TRIFOCAL IOL PROVIDED SATISFACTORY VISUAL OUTCOMES AND QUALITY OF VISION AND LIFE, WHICH RESULTED IN A HIGH RATE OF SPECTACLE INDEPENDENCE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSION VIA LITERATURE ARTICLE PURPOSE TO REPORT THE VISUAL OUTCOMES AND QUALITY OF VISION AND LIFE AFTER BILATERAL IMPLANTATION OF A SINGLE-PIECE TRIFOCAL INTRAOCULAR LENS (IOL) IN CHINESE PATIENTS. THIS WAS A PROSPECTIVE, OBSERVATIONAL CASE SERIES INCLUDED PATIENTS WHO UNDERWENT CATARACT SURGERY OR REFRACTIVE LENS EXCHANGE WITH BILATERAL IMPLANTATION OF PANOPTIX BETWEEN (B)(6) 2021 AT THE (B)(6) HOSPITAL. THE STUDY WAS APPROVED BY THE HOSPITAL ETHICS COMMITTEE AND WAS ADHERED TO THE TENETS OF THE DECLARATION OF HELSINKI. WRITTEN INFORMED CONSENT WAS OBTAINED FROM ALL THE PARTICIPANTS. INCLUSION CRITERIA WERE AS FOLLOWS: AGE OLDER THAN 40 YEARS, STRONG VISUAL DEMAND FOR NEAR TASKS, TARGET REFRACTION OF EMMETROPIA IN BOTH EYES, AND EXPECTED POSTOPERATIVE MONOCULAR CORRECTED DISTANCE VISUAL ACUITY (CDVA) OF 20/25 OR BETTER. EXCLUSION CRITERIA WERE AS FOLLOWS: INTERVAL OF >6 MONTHS BETWEEN THE FIRST-EYE AND SECOND-EYE SURGERIES, NEED FOR TORIC IOLS, USE OF SYSTEMIC OR OCULAR MEDICATIONS THAT MAY AFFECT VISION, PREEXISTING OCULAR CONDITIONS OR SYSTEMIC DISEASES THAT COULD AFFECT VISION, HISTORY OF OCULAR TRAUMA OR PRIOR OCULAR SURGERY, AND INTRAOPERATIVE COMPLICATIONS. THIS CASE IS ABOUT 1 PATIENT SCORED GLARE AS 4 (SEVERE TO VERY SEVERE) AND SATISFACTION SCORE AS 2 (DISSATISFIED), DESPITE SATISFACTORY DRIVING PERFORMANCE, SUGGESTING THAT GLARES COULD BE MORE BOTHERSOME THAN HALOS, WHICH OCCUR IN THE DARK ONLY. LITERATURE CITATION: CHANG JSM ET AL., CLINICAL OUTCOME OF A QUADRIFOCAL (TRIFOCAL) INTRAOCULAR LENS IN CHINESE PATIENTS: PROSPECTIVE, OBSERVATIONAL CASE SERIES. J CATARACT REFRACT SURG 2023; 49(3):246¿252.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245168 ACRYSOF IQ PANOPTIX TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON NI ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other CENTURION VISION SYSTEM.| DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.