BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM

    MDR report key: 19276329 · Received May 9, 2024

    Report

    Report Number
    1119421-2024-00888
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    March 14, 2024
    Report Date
    July 31, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    KYB
    UDI-DI
    00380652394789
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED. ONLY THE LENS WAS RETURNED IN THE CARTON. THE LENS WAS REPLACED INTO A BASE COMPONENT OF A LENS CASE PLACED INTO A BAG. SOLUTION WAS DRIED ON THE LENS. THE OPTIC CENTER WAS CRACKED. THE OPTIC WAS TORN FROM THE EDGE, THROUGH THE CENTER AND TO THE OPPOSITE EDGE (STILL ATTACHED AT THE EDGE). PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. A QUALIFIED VISCOELASTIC WAS INDICATED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THE OPTIC WAS CRACKED AND TORN ALMOST INTO TWO PIECES. THE DEVICE WAS NOT RETURNED FOR AN EVALUATION. THE INITIAL REPORT DESCRIPTION INDICATED THAT THE LENS OPTIC CRACKED, BROKEN DURING DELIVERY. THE FOLLOW UP INFORMATION CONFIRMED THAT THE LENS WAS REMOVED FROM THE EYE THE SAME DAY. IT CANNOT BE DETERMINED IF THE LENS AND PLUNGER WERE IN ACCEPTABLE POSITIONS FOR DELIVERY PRIOR TO THE LENS DAMAGE OCCURRING. THE INSTRUCTION FOR USE (IFU) INSTRUCTS: AFTER THE LENS HAS BEEN ADVANCED TO THE NOZZLE LINE, THE LENS SHOULD BE VISUALLY INSPECTED TO DETERMINE THE POSITION OF THE HAPTICS. THE PLUNGER SHOULD BE IN CONTACT WITH THE TRAILING OPTIC EDGE. AFTER CONFIRMING THE LENS IS PROPERLY POSITIONED AND THE HAPTICS ARE FOLDED PROPERLY, PROCEED WITH LENS IMPLANTATION. PROCEEDING WITH IMPLANTATION OF A MISFOLDED HAPTIC OR A LENS THAT APPEARS TO BE "OUT OF POSITION" CAN RESULT IN A BROKEN HAPTIC OR OTHER NEGATIVE OUTCOME, SINCE THE HAPTIC MAY BE TRAPPED AND STRETCHED, AND/OR PINCHED AND SHEARED BY THE MOVING PLUNGER. IT IS UNKNOWN IF AN ADEQUATE AMOUNT OF VISCOELASTIC WAS ADDED TO THE DEVICE PRIOR TO DELIVERY. THE 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 MILLILITER 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 AN INADEQUATE AMOUNT OF VISCOELASTIC WAS PRESENT IN THE DEVICE, THE LENS WOULD NOT BE ADEQUATELY COVERED. THIS COULD RESULT IN LENS DAMAGE DURING THE DELIVERY ATTEMPT. 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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN D.10., 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 QUALIFIED VISCOELASTIC WAS INDICATED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. 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 HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS OPTIC CRACKED BROKEN DURING DELIVERY. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489225 ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR KYB ALCON RESEARCH, LLC - HUNTINGTON AU00T0 15663546 00380652394789

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.