BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 23632094 · Received November 24, 2025

    Report

    Report Number
    1119421-2025-03011
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 29, 2025
    Report Date
    December 29, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652394840
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6. AND H.11. THE USED SAMPLE WAS RETURNED LOOSE INSIDE THE CARTON. THE LENS STOP AND PLUNGER LOCK WERE REMOVED. THE PLUNGER WAS ORIENTED CORRECTLY. VISCOELASTIC WAS DRIED IN THE DEVICE. THE LENS APPEARED TO BE REPLACED UPSIDE DOWN INTO THE LOADING AREA FOR RETURN SHIPMENT. ONE HAPTIC WAS MISFOLDED UNDER THE OPTIC, TYPICAL OF A PREVIOUS PLUNGER UNDERRIDE DURING DELIVERY ATTEMPT. THE HAPTIC WAS ADHERED TO THE POSTERIOR OF THE OPTIC IN DRIED SOLUTION. THE OTHER HAPTIC WAS BROKEN IN THE HAPTIC/OPTIC JUNCTION. THE OPTIC WAS TORN, SPLIT, AND CRACKED IN THIS SAME HAPTIC/OPTIC JUNCTION. THE NOZZLE HAS LIGHT STRESS LINES ON THE ANTERIOR TIP. THE BEVELED ANTERIOR AREA OF THE TIP WAS BENT SLIGHTLY BACKWARD. FIVE PHOTOS WERE PROVIDED. PHOTO ONE WAS OF THE ANTERIOR VIEW OF THE CARTON. PHOTO TWO WAS THE LENS INFORMATION END CAP. PHOTO THREE DISPLAYED THE LENS PLACED ONTO THE IMPLANT REPLY CARD. SOLUTION WAS DRIED ON THE LENS. THE LENS APPEARS TO BE ANTERIOR SURFACE UP. ONE HAPTIC WAS FOLDED ONTO THE OPTIC. THE OTHER HAPTIC WAS BROKEN IN THE GUSSET AREA. THE BROKEN HAPTIC WAS PLACED NEAR THE DAMAGED AREA. PHOTO FOUR DISPLAYED THE POSTERIOR VIEW OF THE CARTON. PHOTO FIVE APPEARS TO BE THE LENS REPLACED INTO THE LOADING AREA OF THE USED DEVICE. THE PLUNGER WAS RETRACTED TOWARD THE START OF THE LOADING AREA. THE LENS APPEARED TO BE POSTERIOR SURFACE UP. THE ONE HAPTIC WAS FOLDED ONTO THE ANTERIOR OPTIC SURFACE. THE OTHER BROKEN HAPTIC WAS INSIDE THE LOADING AREA. A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. THE DEVIATION REVIEW DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS. THE VISCOELASTIC INFORMATION WAS NOT PROVIDED. IT IS UNKNOWN IF A QUALIFIED VISCOELASTIC WAS USED. THE PRODUCT INVESTIGATION COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED COMPLAINT. BASED ON THE PROVIDED PHOTOS AND THE RETURNED USED SAMPLE, THE REPORTED BROKEN HAPTIC DAMAGE WAS OBSERVED. IT IS UNKNOWN IF A QUALIFIED VISCOELASTIC WAS USED. A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. THE DEVIATION REVIEW DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS. THE PHOTOS INCLUDE PHOTOS OF THE USED LENS SHOWN REMOVED FROM THE USED DEVICE. THE LENS WAS IN THE SAME CONDITION AS RECEIVED (HAPTIC AND OPTIC DAMAGE). THE LENS WAS RETURNED IN THE USED DEVICE LOADING AREA. THIS CONFIRMS THAT THE USED LENS WAS REPLACED INTO THE USED DEVICE PRIOR TO RETURN TO THE MANUFACTURING FACILITY. THE PLUNGER WAS RETRACTED. THE PLUNGER POSITION IN RELATION TO THE BROKEN HAPTIC DURING ADVANCEMENT CANNOT BE DETERMINED. THE IFU INSTRUCTS: AFTER THE LENS HAS BEEN ADVANCED TO THE NOZZLE LINE, THE LENS SHOULD BE VISUALLY INSPECTED TO DETERMINE THE POSITION OF THE HAPTICS. THE PLUNGER SHOULD BE IN CONTACT WITH THE TRAILING OPTIC EDGE. AFTER CONFIRMING THE LENS IS PROPERLY POSITIONED AND THE HAPTICS ARE FOLDED PROPERLY, PROCEED WITH LENS IMPLANTATION. PROCEEDING WITH IMPLANTATION OF A MISFOLDED HAPTIC OR A LENS THAT APPEARS TO BE ¿OUT OF POSITION¿ CAN RESULT IN A BROKEN HAPTIC OR OTHER NEGATIVE OUTCOME, SINCE THE HAPTIC MAY BE TRAPPED AND STRETCHED, AND/OR PINCHED AND SHEARED BY THE MOVING PLUNGER. EVIDENCE OF A PREVIOUS PLUNGER UNDERRIDE WAS ALSO OBSERVED WITH THE MISFOLDED HAPTIC ADVANCED UNDERNEATH THE OPTIC AND ADHERED TO THE POSTERIOR OF THE OPTIC IN DRIED SOLUTION. A PLUNGER UNDERRIDE MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THE REPORTED BROKEN HAPTIC DAMAGE. PLUNGER UNDERRIDE MAY OCCUR: ¿ DUE TO RAPID ADVANCEMENT FASTER THAN THE IFU RECOMMENDED RATE. ¿ DUE TO THE USE OF A NON-QUALIFIED VISCOELASTIC. MATERIAL PROPERTIES OF NON-QUALIFIED OVDS MAY CONTRIBUTE TO UNDERFILL, OVERFILL, MISFOLDING OF THE HAPTICS, OR OTHER INCONSISTENT FOLDING OUTCOMES. ¿ IF INADEQUATE VISCOELASTIC IS PLACED IN THE DEVICE, THIS WILL CAUSE INADEQUATE COVERAGE OF THE LENS FOLD PATH WHICH MAY CAUSE THE LENS TO ADVANCE INCORRECTLY OR BECOME ¿STUCK¿ IN THE DEVICE ALLOWING THE PLUNGER TO UNDERRIDE THE LENS. ¿ IF THE OPERATING ROOM TEMPERATURE IS TOO HIGH (> 23°C / 73° F) LENS FOLDING CONSISTENCY IS NEGATIVELY AFFECTED, THE LENS IS MORE ADHERENT AND THIS MAY INHIBIT LENS ADVANCEMENT. ANY OF THE ABOVE LISTED CAUSES ALONE, OR IN COMBINATION, MAY CREATE THE REPORTED EVENT. 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 NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED THE IOL WAS FOUND WITH ONE OF THE HAPTICS BROKEN. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT CONTACT AND SURGERY COMPLETED SAME DAY WITH REPLACEMENT LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490339 ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON AU00T0 15815363 00380652394840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN VISCOELASTIC