BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 21846933 · Received April 16, 2025

    Report

    Report Number
    1119421-2025-01034
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 12, 2025
    Report Date
    June 2, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION PROVIDED IN H.6. CORRECTION: ON INITIAL MDR THE PRODUCT CODE OF A141401 WAS AN ERROR. IT SHOULD HAVE BEEN A150204 ON THE ORIGINAL MDR. ADDITIONAL INFORMATION WAS PROVIDED IN D.9., H.3., H.6. AND H.11. THE DEVICE WITH THE LENS WAS RETURNED IN THE BLISTER TRAY INSIDE THE CARTON. THE PLUNGER LOCK AND LENS STOP HAVE BEEN REMOVED. THE PLUNGER WAS ORIENTED CORRECTLY. AN ABUNDANCE OF VISCOELASTIC WAS OBSERVED IN THE DEVICE. VISCOELASTIC WAS ALSO OBSERVED ON THE EXTERIOR OF THE DEVICE. THE PLUNGER WAS ADVANCED INTO THE NOZZLE AREA AND WAS IN CONTACT WITH THE TRAILING OPTIC EDGE. A PLUNGER OVERRIDE WAS NOT OBSERVED UPON RETURN. THE LENS WAS ADVANCED TO ALMOST MID NOZZLE. THE LEADING HAPTIC WAS EXTENDED ALONG THE RIGHT SIDE OF THE DEVICE. THE TRAILING HAPTIC WAS MISFOLDED OVER THE PLUNGER TIP. THE NOZZLE WAS CLEANED FOR FURTHER EVALUATION. THE LENS WAS REMOVED DURING CLEANING. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. A NON QUALIFIED VISCOELASTIC WAS INDICATED. THE LENS WAS ADVANCED TO ALMOST MID NOZZLE. THE TRAILING HAPTIC WAS MISFOLDED OVER THE PLUNGER TIP. THIS MAY HAVE BEEN INTERPRETED AS PART OF THE COMPLAINT. IT IS UNKNOWN IF THE PLUNGER HAS BEEN RETRACTED AND ADVANCED A SECOND TIME. THE ROOT CAUSE MAY BE RELATED TO A FAILURE TO FOLLOW THE IFU. A NON QUALIFIED VISCOELASTIC WAS INDICATED. THE INSTRUCTIONS FOR USE (IFU) 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. AN ABUNDANCE OF VISCOELASTIC WAS OBSERVED IN THE DEVICE WITH VISCOELASTIC ALSO OBSERVED ON THE EXTERIOR OF THE DEVICE. THIS MAY INDICATE THAT THE DEVICE WAS OVERFILLED AND MAY HAVE BEEN A CONTRIBUTING FACTOR. 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. 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. PLUNGER OVERRIDE 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 THE DEVICE IS OVERFILLED WITH OVD, THIS CAN PREVENT THE TRAILING HAPTIC FROM BEING PLACED PROPERLY OR MOVE THE LENS OUT OF POSITION RESULTING IN MISFOLDING. IF THE OPERATING ROOM TEMPERATURE IS TOO HIGH (MORE THAN 23 DEGREE C OR 73 DEGREE 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. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. 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

    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). 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

    A HEALTHCARE PROFESSIONAL REPORTED WITH DESCRIPTION FAULTY LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE LENS WAS SQUASHED BY THE PLUNGER UPON PRIMING. THE LENS DID NOT ADVANCE. THE SURGERY WAS COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT CONTACT OR IMPACT. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 3 OF 3 FILES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116764 ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON ACU0T0 15862466

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NUVISC 5006009 OVD