BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 19594938 · Received June 24, 2024

    Report

    Report Number
    1119421-2024-01203
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Report Date
    September 13, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    KYB
    UDI-DI
    00380652394802
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6 AND H.11. THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. VISCOELASTIC WAS NOT PROVIDED. IT IS UNKNOWN IF A QUALIFIED PRODUCT WAS USED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. IT IS UNKNOWN IF A QUALIFIED VISCOELASTIC WAS USED. THE IFU (INSTRUCTIONS FOR USE) INSTRUCTS: DURING DEVICE PREPARATION AND IMPLANTATION OF THE COMPANY IOL (INTRA OCULAR LENS) WITH THE 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. LENS MAY BECOME STUCK IN THE DEVICE: IF INADEQUATE VISCOELASTIC IS PLACED IN THE DEVICE THIS WILL CAUSE INADEQUATE COVERAGE OF THE LENS FOLD PATH WHICH MAY CAUSE THE LENS TO BECOME STUCK IN THE DEVICE. 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 OPERATING ROOM TEMPERATURE IS TOO HIGH (GREATER THAN 23C / 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. DUE DILIGENCE HAS BEEN PERFORMED IN AN ATTEMPT TO OBTAIN FURTHER INFORMATION ON THIS EVENT. THE REPORTER 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).

    Description of Event or Problem · 0

    A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS ISSUE WITH THE LEADING HAPTIC AND THE WAY IT WAS FOLDED IN THE CHAMBER. IT DID NOT ADVANCE PROPERLY OUT INTO THE EYE AND DID NOT MAKE IT THROUGH THE INCISION PROPERLY. THE PROCEDURE WAS COMPLETED WITH THE BACK UP LENS AND IT HAPPENED DURING SURGERY. THERE WAS NO PATIENT HARM AND NO ISSUES WITH THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2156127 ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR KYB ALCON RESEARCH, LLC - HUNTINGTON AU00T0 15521161 00380652394802

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED REPLACEMENT LENS