BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 21513336 · Received March 4, 2025

    Report

    Report Number
    1119421-2025-00583
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    June 14, 2024
    Report Date
    June 13, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652394789
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE AND THE LENS WERE RETURNED LOOSE IN A PLASTIC BAG. THE PLUNGER LOCK AND LENS STOP HAVE BEEN REMOVED. THE PLUNGER WAS ORIENTED CORRECTLY. VISCOELASTIC WAS DRIED IN THE DEVICE. THE PLUNGER WAS RETRACTED TO MID-NOZZLE. NO ISSUES OR ABNORMALITIES OBSERVED. THE LENS WAS RETURNED OUTSIDE THE DEVICE ADHERED BY VISCOELASTIC TO THE PLASTIC BAG AND NOT INSIDE THE DEVICE AS DESCRIBED. VISCOELASTIC WAS DRIED ON THE LENS. THE PATTEN OF THE DRIED VISCOELASTIC DOES GIVE THE LENS A "SCRATCHED" CHARACTERISTIC. THE LENS WAS CLEANED WITH KLRP FOR FURTHER EVALUATION. NO SCRATCHES WERE OBSERVED. BOTH HAPTICS WERE PLIABLE WHEN MANIPULATED. NO ISSUES OBSERVED. A FOLD INSPECTION WAS CONDUCTED USING FOLDING TWEEZERS. THE LENS FOLDED AND UNFOLDED WITH NO ABNORMALITIES OBSERVED. A DIMENSIONAL (PLAN VIEW) INSPECTION WAS CONDUCTED AND THE LENS MET SPECIFICATION PER THE APPROVED (PLAN VIEW) TEMPLATE. NO HAPTIC OR OPTIC DAMAGE OBSERVED. PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. A QUALIFIED VISCOELASTIC WAS INDICATED. NO PROBLEMS WERE OBSERVED WITH THE RETURNED DEVICE. THE PLUNGER WAS ORIENTED CORRECTLY. VISCOELASTIC WAS OBSERVED IN THE DEVICE. NO DAMAGE OR ABNORMALITIES OBSERVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS SCRATCHED, HAPTIC DID NOT FOLD AFTER IMPLANTATION. THERE WAS PATIENT CONTACT AND THE PROCEDURE COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697598 ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON AU00T0 15685487 00380652394789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DUOVISC VISCOELASTIC SYSTEM.| MONARCH II LOADING FORCEPS.