BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 17379184 · Received July 24, 2023

    Report

    Report Number
    1119421-2023-01307
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    June 10, 2023
    Report Date
    September 13, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    KYB
    UDI-DI
    00380652394864
    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

    A SAMPLE DEVICE 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 WITH THE LENS WAS RETURNED LOOSE IN A BAG. THE PLUNGER LOCK AND LENS STOP WERE REMOVED. THE PLUNGER WAS ORIENTED CORRECTLY. VISCOELASTIC WAS OBSERVED IN THE DEVICE. THE PLUNGER WAS ADVANCED TO MID-NOZZLE AND HAS UNDERRODE THE LENS. THIS HAS RESULTED IN THE LENS BECOMING STUCK IN THE DEVICE. THE LENS WAS LOCATED AT MID-NOZZLE. THE OPTIC WAS MISFOLDED UP IN THE DEVICE. THE TRAILING HAPTIC WAS MISFOLDED, LOOPED AROUND THE PLUNGER TIP AND ADVANCED UNDER THE OPTIC TOWARD THE RIGHT SIDE OF THE DEVICE. THE LEADING HAPTIC WAS EXTENDED. THE NOZZLE WAS REMOVED AND CLEANED FOR FURTHER EVALUATION. THE LENS WAS REMOVED DURING CLEANING. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. A PLUNGER UNDERRIDE WAS OBSERVED RESULTING IN THE LENS BECOMING STUCK IN THE DEVICE. THE ROOT CAUSE FOR THE REPORTED COMPLAINT MAY BE RELATED TO A FAILURE TO FOLLOW THE INSTRUCTIONS FOR USE (IFU). A NON-QUALIFIED VISCOELASTIC WAS INDICATED. THE IFU INSTRUCTS: DURING DEVICE PREPARATION AND IMPLANTATION OF THE LENS WITH 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. PLUNGER UNDERRIDE MAY OCCUR: DUE TO RAPID ADVANCEMENT FASTER THAN THE IFU RECOMMEND RATE. DUE TO THE USE OF A NON-QUALIFIED VISCOELASTIC. THE USE OF AN UNQUALIFIED OVD MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING THE DEVICE PREPARATION AND IMPLANTATION STEPS. 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 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 (> 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. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS STUCK IN THE INJECTOR DURING INSERTION. THERE WAS PATIENT CONTACT WITH THE PRODUCT BUT THERE WAS NO PATIENT HARM. THE SURGERY WAS COMPLETED WITH BACK UP LENS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470860 ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR KYB ALCON RESEARCH, LLC - HUNTINGTON AU00T0 15386574 00380652394864

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VISCOELASTIC AMO HEALON PRO.