BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF MULTIPIECE IOL

    MDR report key: 24839753 · Received April 10, 2026

    Report

    Report Number
    1119421-2026-00753
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Report Date
    April 10, 2026
    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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS BROWN LIKE MATURE CATARACT WHEN VIEWED FROM THE FRONT. CURRENTLY, THERE WAS NO DECREASE IN VISUAL ACUITY. IT WAS LIGHT BROWN AND THERE WERE NO SIGNS OF GLISTENING. THE CENTER OF THE IOL WAS NOT BROWN. THERE WERE NO PLANS FOR FUTURE PROCEDURES SUCH AS IOL REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT WHITISH TO SLIGHTLY BROWNISH OPACIFICATIONS ARE OBSERVED ON THE ANTERIOR AND POSTERIOR SURFACES OF THE IOLS AND MILD GLISTENINGS WERE PRESENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900399 ACRYSOF MULTIPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON MA50BM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown