BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL

    MDR report key: 19904740 · Received August 5, 2024

    Report

    Report Number
    1119421-2024-01509
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 5, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORT DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. LITERATURE CITATION- LWOWSKI C, ET AL., 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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 1 CASE OF 17-DEGREE MIS ROTATION WAS NOTED, BUT THE PATIENT REFUSED A CORRECION BECAUSE OF GOOD SUBJECTIVE VISUAL QUALITY, WITH AN UNCORRECTED NEAR VISUAL ACUITY OF 0.2 LOGMAR (SNELLEN 20/32) AND CDVA OF 0.1 LOG MAR (SNELLEN 20/25).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274674 ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON NI ASKU

    Patients

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