BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX TRIFOCAL IOL

    MDR report key: 20536272 · Received October 25, 2024

    Report

    Report Number
    1119421-2024-02092
    Event Type
    Injury
    Date Received
    October 25, 2024
    Report Date
    October 25, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 REFRACTIVE LENS EXCHANGE WHO IS GETTING IT, WHAT ARE THEY GETTING, HOW ARE THEY DOING THIS STUDY VALIDATES REFRACTIVE LENS EXCHANGE AS AN ATTRACTIVE, VIABLE SURGICAL OPTION FOR AMETROPIC PATIENTS WITH PRESBYOPIA WHO DESIRE SPECTACLE INDEPENDENCE. THUS, THE AUTHORS BELIEVE THAT THE TIME IS APPROPRIATE FOR ALL REFRACTIVE SURGEONS, WHO HAVE THE FULL ARMAMENTARIUM OF CORNEAL AND LENS BASED TECHNOLOGIES AVAILABLE IN THEIR PRACTICES, TO CONFIDENTLY OFFER REFRACTIVE LENS EXCHANGE AS A SURGICAL OPTION FOR THOSE SEEKING SPECTACLE FREE DISTANCE AND NEAR VISION. LITERATURE CITATION: LAUREN F. ONG ET AL, REFRACTIVE LENS EXCHANGE ¿ WHO IS GETTING IT, WHAT ARE THEY GETTING, HOW ARE THEY DOING? CURR OPIN OPHTHALMOL JUL-2023, 34 (4):280¿289 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 PURPOSE OF THIS ARTICLE IS TO PROVIDE A REVIEW OF THE LITERATURE ON REFRACTIVE LENS EXCHANGE AND PRESENT A RETROSPECTIVE ANALYSIS OF 55 PATIENTS WHO UNDERWENT REFRACTIVE LENS EXCHANGE AT A SINGLE PRACTICE. A RETROSPECTIVE COHORT STUDY WAS CONDUCTED ON PATIENTS WHO UNDERWENT BILATERAL OR UNILATERAL RLE SURGERY BY FOUR SURGEONS (D.T., A.M., B.N., AND J.L.) OF A SINGLE CENTER (COASTAL VISION MEDICAL GROUP) FROM JANUARY 1, 2020 TO SEPTEMBER 30, 2022. ALL PREOPERATIVE ASSESSMENTS AND SURGERIES WERE PERFORMED BY D.T., A.M., B.N., AND J.L. POSTOPERATIVE ASSESSMENTS WERE CONDUCTED BY THE AFOREMENTIONED SURGEONS OR AFFILIATED OPTOMETRISTS. A VARIETY OF LENSES WERE USED BASED ON PATIENT NEEDS AND SURGEON JUDGMENT INCLUDING NONTORIC MONOFOCAL, NONTORIC MULTIFOCAL, TORIC MULTIFOCAL, TORIC MONOFOCAL, EDOF, AND LIGHT ADJUSTABLE LENSES. CONCLUSION: THE STRENGTH OF THIS STUDY IS THAT ALTHOUGH THE DATA COMES FROM A SINGLE PRACTICE, IT WAS FROM FOUR DIFFERENT SURGEONS. LIMITATIONS OF THIS STUDY INCLUDE THE SMALL SAMPLE SIZE AND LIMITED FOLLOW-UP. ALTHOUGH A WIDE RANGE OF PRESBYOPIA-ADDRESSING IOLS WERE USED, NOT ALL WERE REPRESENTED SUCH AS ACCOMMODATIVE OR SMALL-APERTURE LENSES. NEVERTHELESS, THIS STUDY ILLUMINATES SOME INTERESTING FACTS ABOUT REFRACTIVE LENS EXCHANGE ¿ A PROCEDURE GAINING MORE POPULARITY AMONG SURGEONS AND THEIR PATIENTS. THE MAJORITY OF THESE PATIENTS INITIALLY SOUGHT A LASIK CONSULTATION BUT WERE INTRODUCED TO REFRACTIVE LENS EXCHANGE. THE PRIMARY REASON FOR CONSULTATION FOR THESE PATIENTS WAS INDEPENDENCE FROM SPECTACLES FOR DISTANCE AND NEAR VISION. MOST OF THE PATIENTS HAD HYPEROPIA AND PRESBYOPIA. THE MAJORITY OF THE PATIENTS ACHIEVED INTENDED POSTOPERATIVE REFRACTION AND WERE SATISFIED WITH THEIR DISTANCE AND NEAR VISION. THIS STUDY VALIDATES REFRACTIVE LENS EXCHANGE ASAN ATTRACTIVE, VIABLE SURGICAL OPTION FOR AMETROPIC PATIENTS WITH PRESBYOPIA WHO DESIRE SPECTACLE INDEPENDENCE. THUS, THE AUTHORS BELIEVE THAT THE TIME IS APPROPRIATE FOR ALL REFRACTIVE SURGEONS, WHO HAVE THE FULL ARMAMENTARIUM OF CORNEAL AND LENS-BASED TECHNOLOGIES AVAILABLE IN THEIR PRACTICES, TO CONFIDENTLY OFFER REFRACTIVE LENS EXCHANGE AS A SURGICAL OPTION FOR THOSE SEEKING SPECTACLE-FREE DISTANCE AND NEAR VISION. THIS FILE WAS CREATED FOR THE PATIENT UNDERWENT IOL EXCHANGE FOR ONE EYE EACH AFTER THE INITIAL RLE PROCEDURE DUE TO INTOLERABLE GLARE AND HALO FROM THEIR MULTIFOCAL LENS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819951 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