BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 19348894 · Received May 20, 2024

    Report

    Report Number
    1119421-2024-00962
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 31, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652394703
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. A QUALIFIED VISCOELASTIC WAS INDICATED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED. NOT ENOUGH INFORMATION WAS PROVIDED FOR FURTHER INVESTIGATION. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTS: FULLY INSERT THE OPHTHALMIC VISCOSURGICAL DEVICE (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 A 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. TAKE AT LEAST 7 SECONDS TO GENTLY FOLD THE INTRAOCULAR LENS (IOL) BY ADVANCING THE PLUNGER FORWARD IN ONE SMOOTH, CONTINUOUS MOTION UNTIL THE FRONT EDGE OF THE OPTIC IS EVEN WITH THE ¿FILL-TO¿ LINE ON THE NOZZLE. DO NOT ALLOW ANY PORTION OF THE LENS TO EXIT THE NOZZLE TIP. AT THIS POSITION THE BLUE SPRING WILL CONTACT THE CLEAR MAIN BODY. IT IS IMPORTANT TO NOT ADVANCE THE PLUNGER ABRUPTLY TO FOLD THE IOL AS IMPROPER FOLDING AND LENS DAMAGE MAY OCCUR. DUE DILIGENCE HAS BEEN PERFORMED IN AN ATTEMPT TO OBTAIN FURTHER INFORMATION ON THIS EVENT. THE FACILITY 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).

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION WAS PROVIDED IN H.6. A0202, A040603 WAS MISSED TO SUBMIT ON INITIAL MDR. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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).

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) DID NOT FOLD CORRECTLY, THE LEG WENT FORWARD AND THE LENS WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856692 ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON AU00T0 ASKU 00380652394703

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PROVISC.