BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX TRIFOCAL IOL

    MDR report key: 19861292 · Received July 30, 2024

    Report

    Report Number
    1119421-2024-01443
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    July 1, 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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION - LWOWSKI C, RUSEV V, KOHNEN T.ASSESSMENT OF VISUAL HABITUATION MEASURED WITH THE HALO & GLARE SIMULATOR AND ITS IMPACT ON PATIENT SATISFACTION FOLLOWING QUADRIFOCAL IOL IMPLANTATION. JOURNAL OF REFRACTIVE SURGERY. 2023. 39; 8: 510-517. 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: ASSESSMENT OF VISUAL HABITUATION MEASURED WITH THE HALO AND GLARE SIMULATOR AND ITS IMPACT ON PATIENT SATISFACTION FOLLOWING QUADRIFOCAL IOL IMPLANTATION. THE STUDY CONCLUDED THAT DIFFRACTIVE MULTIFOCAL IOLS ARE A STABLE TREATMENT FOR PRESBYOPIA AND OR CATARACT WITH A HIGH SPECTACLE INDEPENDENCE RATE. VISUAL DISTURBANCES CAUSED BY THEIR OPTICS DO NOT DECREASE SIGNIFICANTLY BETWEEN 3 AND 6 MONTHS AFTER SURGERY. HABITUATION AND NEUROADAPTATION PLAY A SIGNIFICANT ROLE IN PATIENT SATISFACTION AND CONTRAST SENSITIVITY DURING AND POSSIBLY BEYOND THAT PERIOD. ONE PATIENT DEVELOPED CLINICALLY SIGNIFICANT POSTERIOR CAPSULE OPACIFICATION THAT WAS TREATED AFTER THE PATIENT COMPLETED THE STUDY. 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

    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.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED VIA LITERATURE ARTICLE TO EVALUATE THE LEVELS OF HABITUATION AND ITS INFLUENCE ON OUTCOME SATISFACTION IN PATIENTS WHO UNDERWENT BILATERAL MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANTATION. A TOTAL OF 24 PATIENTS UNDERWENT BILATERAL MULTIFOCAL IOL IMPLANTATION SURGERY WITH THE COMPANY TRIFOCAL DIFFRACTIVE IOL FOLLOWING CATARACT EXTRACTION OR FOR REFRACTIVE PURPOSES. DATA WERE COLLECTED 3 AND 6 MONTHS AFTER SURGERY, WHICH INCLUDED SUBJECTIVE REFRACTION, CORRECTED AND UNCORRECTED VISUAL ACUITY (DISTANCE, INTERMEDIATE, NEAR), A CONTRAST SENSITIVITY TEST, SIMULATION WITH THE HALO AND GLARE SIMULATOR, TWO VISUAL QUALITY SURVEYS, AND A SLIT-LAMP EXAMINATION BY AN OPHTHALMOLOGIST. THIS FILE IS ABOUT ONE EYE WHICH HAD A CLINICALLY SIGNIFICANT POSTERIOR CAPSULE OPACIFICATION THAT WAS TREATED AFTER THE PATIENT COMPLETED THE STUDY. NO POSTERIOR CAPSULE OPACIFICATION WAS DETECTED IN THE REMAINING CASES. LWOWSKI C, RUSEV V, KOHNEN T.ASSESSMENT OF VISUAL HABITUATION MEASURED WITH THE HALO & GLARE SIMULATOR AND ITS IMPACT ON PATIENT SATISFACTION FOLLOWING QUADRIFOCAL IOL IMPLANTATION. JOURNAL OF REFRACTIVE SURGERY. 2023. 39; 8: 510-517.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208058 ACRYSOF IQ PANOPTIX TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON NI ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CONJUCAIN.| IOLMASTER 500 OR 700 (CARL ZEISS MEDITEC AG.| LENSX LASER SYSTEM.