BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 20450275 · Received October 15, 2024

    Report

    Report Number
    1119421-2024-02012
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Report Date
    October 15, 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
    VA, 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: INCIDENCE OF POSTSURGICAL INTRAOCULAR INFLAMMATION 6 MONTHS AFTER IMPLANTATION WITH A MULTIFOCAL INTRAOCULAR LENS. THIS STUDY ASSESSED THE INCIDENCE OF POSTSURGICAL INTRAOCULAR INFLAMMATION AFTER CATARACT EXTRACTION BY PHACOEMULSIFICATION AND IMPLANTATION WITH COMPANY INTRAOCULAR LENSES (IOLS) PRODUCED USING AN UPDATED MANUFACTURING PROCESS. OCULAR AES WERE REPORTED IN 17 PERCENTAGE OF ALL EYES. THE MOST COMMON OCULAR AES INCLUDED INTRAOCULAR PRESSURE INCREASE, POSTERIOR CAPSULE OPACIFICATION AND VISUAL ACUITY REDUCTION. OCULAR SAES WERE REPORTED IN 1.2 PERCENTAGE OF ALL EYES. THE MOST COMMON SERIOUS OCULAR AE WAS VITRECTOMY. OCULAR SAES WERE RELATED DEVICE DISLOCATION, IOL REPOSITIONING, AND GLARE. THREE EVENTS OF DEVICE DISLOCATION WERE UNRELATED TO THE DEVICE. OCULAR ADVERSE DEVICE EFFECTS WERE REPORTED IN 1.5 PERCENTAGE OF ALL EYES AND INCLUDED. THE MOST COMMON ADVERSE DEVICE EFFECTS WERE HALO VISION 0.63 PERCENTAGE AND GLARE 0.51 PERCENTAGE. THERE WERE 16 DEVICE DEFICIENCIES REPORTED WHICH INCLUDED SCRATCHED MATERIAL 0.12 PERCENTAGE AND FAILURE TO FOLD .09 PERCENTAGE. INCIDENCE RATES WERE COMPARED WITH HISTORICAL RATES OF POSTSURGICAL INTRAOCULAR INFLAMMATION. INTRAOCULAR INFLAMMATION RATES WERE SUBSTANTIALLY LOWER THAN THE HISTORIC RATE. LITERATURE REPORT CITATION: PAAUW, J ET AL., INCIDENCE OF POSTSURGICAL INTRAOCULAR INFLAMMATION 6 MONTHS AFTER IMPLANTATION WITH A MULTIFOCAL INTRAOCULAR LENS. CLINICAL OPHTHALMOLOGY. JULY 2024; 18:1971¿1980. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). 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 PUBLISHED AN ARTICLE WITH THE PURPOSE OF ASSESSING THE INCIDENCE OF POSTSURGICAL INTRAOCULAR INFLAMMATION AFTER CATARACT EXTRACTION BY PHACOEMULSIFICATION AND IMPLANTATION OF COMPANY INTRAOCULAR LENSES (IOLS) PRODUCED USING AN UPDATED MANUFACTURING PROCESS. INCIDENCE RATES WERE COMPARED WITH HISTORICAL RATES OF POSTSURGICAL INTRAOCULAR INFLAMMATION. THIS WAS A PROSPECTIVE, MULTICENTER, ACTIVE-SURVEILLANCE POST-APPROVAL STUDY WITH A 6-MONTH FOLLOW-UP. THE STUDY WAS CONDUCTED AT 34 SITES BETWEEN (B)(6) 2022. PATIENTS RECEIVED COMPANY LENSES THAT WERE EITHER +3.0 MULTIFOCAL TORIC OR MULTIFOCAL NON-TORIC. THIS FILE HAS BEEN CREATED FOR BREAK IN 2 EYES WHICH WAS RELATED TO DEVICE. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 12 OF 18.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295014 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON SV25T0 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ACRYSOF RESTOR TORIC SINGLEPIECE IOL