BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 16727423 · Received April 12, 2023

    Report

    Report Number
    1119421-2023-00645
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    March 1, 2023
    Report Date
    April 12, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    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. 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 FILE HAS BEEN OPENED FROM A LITERATURE REPORT: RANDOMIZED MULTICENTER TRIAL TO ASSESS POSTERIOR CAPSULE OPACIFICATION AND GLISTENINGS IN TWO HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES. THERE WERE NO REPORTS OF ADVERSE EVENTS LEADING TO LENS REMOVAL OR UNANTICIPATED ADVERSE DEVICE EFFECTS IN EITHER GROUP. POSTOPERATIVE VISUAL ACUITIES IMPROVED FROM BASELINE IN BOTH IOL GROUPS (P < 0.0001), AND REMAINED STABLE THROUGH THE 3-YEAR FOLLOW-UP PERIOD. GU, RANDOMIZED MULTICENTER TRIAL TO ASSESS POSTERIOR CAPSULE OPACIFICATION AND GLISTENINGS IN TWO HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES, SCIENTIFIC REPORTS 2023: 13(1) P.2822. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A RANDOMIZED MULTICENTER TRIAL WAS PUBLISHED TO ASSESS POSTERIOR CAPSULE OPACIFICATION AND GLISTENINGS IN TWO HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES FROM GERMANY. FOLLOWING THE IMPLANTATION OF THE COMPANY LENS THE PATIENTS' HAD EXPERIENCED GLISTENINGS. THE OVERALL GLISTENING SCORES REMAINED LOW, WITH ONLY 2 SUBJECTS (2.99%) OBSERVING A GLISTENING SCORE OF + 1. UP TO 36-MONTHS. APPROXIMATELY 50% OF THE COMPANY GROUP SHOWED GLISTENING SCORES OF + 2 TO + 4. THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS REPORT IS 2 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108805 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN60WF ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown