BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 21754031 · Received April 2, 2025

    Report

    Report Number
    1119421-2025-00894
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    February 3, 2025
    Report Date
    May 8, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    KYB
    UDI-DI
    00380652394840
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6. AND H.11. THE PRODUCT HAS NOT RETURNED. TWO PHOTOS WERE PROVIDED. ONE PHOTO WAS IDENTIFIED FOR THIS FILE. A LABEL SHOWN ON THIS IMAGE INDICATED MSHD SMILE EYES. THIS PHOTO DISPLAYED A PARTIAL VIEW OF A MONITOR SCREEN. A YELLOW LENS MODEL WAS SHOWN INSIDE THE EYE. TWO METAL SURGICAL INSTRUMENTS WERE SHOWN TILTING THE LENS TOWARD THE CAMERA. THE ONE METAL INSTRUMENT TILTED THE LENS FROM BELOW, SHOWING THE OPTIC EDGE. A RED CIRCLE WAS PLACED ONTO THE AREA OF THE CUSTOMER¿S CONCERN. THE IMAGE WAS TOO BLURRY INSIDE THE CIRCLED AREA IN ORDER TO MAKE A DETERMINATION. A GLARE FROM THE OVERHEAD LIGHTS WAS ALSO VISIBLE AND WHAT APPEARED TO BE SOLUTION WAS AROUND THE EDGES OF THE OPTIC. THE CLARITY OF THE PHOTO WAS TOO POOR TO MAKE A DETERMINATION FOR THE REPORTED DAMAGE. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. VISCOELASTIC INFORMATION WAS NOT PROVIDED. IT IS UNKNOWN IF A QUALIFIED VISCOELASTIC WAS USED. THE ROOT CAUSE CANNOT BE DETERMINED FOR THE REPORTED EVENT. THE EXPLANTED LENS WAS NOT RETURNED FOR AN EVALUATION. PHOTOS WERE PROVIDED. THE PHOTO WITH THE LABEL OF MSHD SMILE EYES WAS IDENTIFIED FOR THIS FILE. BASED ON OUR OBSERVATION OF THE ATTACHED PHOTOS, THE CLARITY IS TOO BLURRY TO MAKE A DETERMINATION. IT IS DIFFICULT TO MAKE A FINAL DETERMINATION WITHOUT EVALUATION OF THE PHYSICAL SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED BASED ON AVAILABLE INFORMATION. IT IS UNKNOWN IF A QUALIFIED VISCOELASTIC WAS USED. THE IFU (INSTRUCTIONS FOR USE) INSTRUCTS: DURING DEVICE PREPARATION AND IMPLANTATION OF THE COMPANY IOL WITH THE COMPANY PRELOADED DELIVERY SYSTEM, AN COMPANY QUALIFIED OPHTHALMIC VISCOELASTIC DEVICE (OVD) SHOULD BE USED. THE USE OF AN UNQUALIFIED OVD MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING THE DEVICE PREPARATION AND IMPLANTATION STEPS. IT IS UNKNOWN IF ADEQUATE VISCOELASTIC WAS USED. THE IFU INSTRUCTS: FULLY INSERT THE OVD CANNULA, PERPENDICULAR TO THE DEVICE, THROUGH THE VISCOELASTIC PORT, LOCATED IN THE LENS STOP PORTION OF THE DEVICE. FILL THE DEVICE UNTIL OVD CAN BE OBSERVED FLOWING TO THE ¿FILL-TO¿ LINE ON THE NOZZLE TIP. THIS WILL REQUIRE APPROXIMATELY 0.2 ML OF OVD. ONLY USE AN COMPANY OVD QUALIFIED FOR USE WITH THE COMPANY PRE-LOADED DELIVERY SYSTEM THAT HAS BEEN ALLOWED TO COME TO THE OPERATING ROOM TEMPERATURE. INFORMATION INDICATED THAT THE LENS WAS EXPLANTED AND EXCHANGED. THE EXPLANTED LENS WAS NOT AVAILABLE TO RETURN. THE REPLACEMENT LENS INFORMATION WAS NOT PROVIDED. DUE DILIGENCE HAS BEEN PERFORMED IN AN ATTEMPT TO OBTAIN FURTHER INFORMATION ON THIS EVENT. THE FACILITY HAS NOT RESPONDED TO REQUESTS FOR FOLLOW-UP INFORMATION. FILE WILL BE REOPENED IF NEW INFORMATION OR THE SAMPLE IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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).

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SMALL DEFECTS WERE OBSERVED ON THE OPTIC EDGE AFTER IMPLANTATION. LENS WAS EXPLANTED IN SECONDARY PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263256 ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR KYB ALCON RESEARCH, LLC - HUNTINGTON AU00T0 15842825 00380652394840

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention