BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 22676439 · Received July 31, 2025

    Report

    Report Number
    1119421-2025-02103
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Report Date
    September 29, 2025
    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
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. LITERATURE CITATION: DUSAN TODOROVIC, ET AL., THE EFFECT OF THREE DIFFERENT ACRYLIC INTRAOCULAR LENSES ON THE GLISTENING FORMATION. DOI. VOJNOSANIT PREGL 2025; 82(1): 37-45. 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

    DURING THE STUDY GLISTENING WAS NOTICED IN 43 PATIENTS (46.7 PERCENT) IN ALL THREE GROUPS. OF THAT NUMBER, 20 (21.7PERCENT) PATIENTS WERE MALE AND 23 (25 PERCENT) FEMALE. THERE WERE 17 PATIENTS EXPERIENCED GLISTENING IN THE SINGLE PIECE HYDROPHOBIC (SPHPHOB) GROUP.

    Description of Event or Problem · 0

    A NON-HEALTH CARE PROFESSIONAL PUBLISHED ORIGINAL ARTICLE WITH A PURPOSE TO EVALUATE THE EFFECT OF THREE DIFFERENT ACRYLIC INTRAOCULAR LENSES (IOL) ON THE GLISTENING FORMATION. THE AIM OF THIS STUDY WAS TO DETERMINE THE INCIDENCE OF GLISTENING FORMATION AFTER THE IMPLANTATION OF THREE DIFFERENT ACRYLIC IOLS DURING THE TWO-YEAR FOLLOW-UP PERIOD. THE STUDY INCLUDED PARTICIPANTS OF BOTH SEXES, OLDER THAN 65 YEARS, WITH A CONFIRMED DIAGNOSIS OF SENILE CATARACT. CATARACT SURGERY WAS PERFORMED IN 93 PATIENTS (93 EYES) WITH DEVELOPED SENILE CATARACTS. ACCORDING TO THE IMPLANTED IOL, PATIENTS WERE EQUALLY DIVIDED INTO THREE GROUPS: GROUP WITH SINGLE-PIECE HYDROPHILIC (SPHPHIL) ACRYLIC IOL (NON-COMPANY LENSES), GROUP WITH SINGLE-PIECE HYDROPHOBIC (SPHPHOB) ACRYLIC IOL (COMPANY LENSES), AND GROUP WITH THREE-PIECE HYDROPHOBIC (TPHPHOB) ACRYLIC IOL (COMPANY LENSES). THE PRESENCE OF GLISTENING WAS MEASURED FIVE TIMES: 1, 6, 12, 18, AND 24 MONTHS AFTER PHACOEMULSIFICATION. ONE MONTH AFTER THE SURGERY, 94.6 PERCENT OF PATIENTS HAD GLISTENING GRADE ZERO, WHILE ONLY 5.4 PERCENT HAD GLISTENING GRADE ONE. DURING THE FIRST POSTOPERATIVE YEAR, A STATISTICALLY SIGNIFICANT DIFFERENCE WAS NOTICED IN EVERY FOLLOWING VISIT COMPARED TO THE PREVIOUS ONE. IN SPHPHOB GROUP (31 PATIENTS) THERE ARE 17 MALE AND 14 FEMALE PATIENTS ARE PRESENT. CLINICAL SIGNS OF GLISTENING IN THE FORM OF GLARE WERE PRESENT IN 9 PATIENTS IN OVER ALL THREE GROUPS OUT OF WHICH FOUR PATIENTS WITH GLARE WERE IN THE SPHPHOB GROUP. THE STUDY WAS CONCLUDED STATING EXISTENCE OF GLISTENING IN ALL TYPES OF TESTED ACRYLIC INTRAOCULAR LENSES. THE STUDY HAS SHOWN A IMPACT ON HYDROPHOBIC MATERIAL ON THE GLISTENING FORMATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277924 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SA60AT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown