BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 19593158 · Received June 24, 2024

    Report

    Report Number
    1119421-2024-01196
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 18, 2024
    Report Date
    September 16, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652484268
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 ADDED 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. A NON-QUALIFIED VISCOELASTIC WAS INDICATED. THE ROOT CAUSE MAY BE RELATED TO A FAILURE TO FOLLOW THE IFU. A NON-QUALIFIED VISCOELASTIC WAS USED IN THE DEVICE. THE IFU INSTRUCTS: DURING DEVICE PREPARATION AND IMPLANTATION OF THE IOL 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 (> 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 PRODUCT HAS NOT BEEN RECEIVED TO EVALUATE. FILE WILL BE REOPENED WHEN PRODUCT IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED VIA REGULATORY AGENCY THAT DURING AN INTRAOCULAR LENS (IOL), IT WAS FOUND THAT THERE WAS A PROBLEM WITH THE LENS INJECTOR. THE LENS IMMEDIATELY STOPPED IMPLANTATION AND WAS REPLACED WITH A LENS OF THE SAME MANUFACTURER AND DEGREE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2173749 ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON AU00T0 15427575 00380652484268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SODIUM HYALURONATE COAGULATION: 1.0ML:20MG.