BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM

    MDR report key: 21536331 · Received March 6, 2025

    Report

    Report Number
    9612169-2025-00333
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    February 3, 2025
    Report Date
    April 21, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652393690
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION PROVIDED IN H.6. AND H.11. CORRECTION: ON INITIAL MDR THE PRODUCT CODE OF A140504 WAS AN ERROR. IT SHOULD HAVE BEEN A140504 ON THE ORIGINAL MDR. THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT WAS OBSERVED. THE DEVICE WAS RETURNED LOOSE IN A PLASTIC BAG. THE LOCK OUT ASSEMBLY HAS BEEN REMOVED, THE NOZZLE HAS BEEN REMOVED AND NOT RETURNED. VISCOELASTIC IS OBSERVED IN THE LENS BAY. THE PLUNGER HAS BEEN PARTIALLY ADVANCED OUT OF THE LENS BAY AND IS ADVANCED OVER AND TO THE LEFT SIDE OF THE IOL (INTRAOCULAR LENS). THE IOL IS ADVANCED JUST PAST THE LENS BAY AND IS MISFOLDED. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED COMPLAINT INCORRECT DEPLOYMENT OF IMPLANT. PLUNGER OVERRIDE WAS OBSERVED. PLUNGER OVERRIDE MAY OCCUR: IF THE LENS HAS BECOME MISALIGNED IN THE LENS BAY DURING THE MANUFACTURING PROCESS. DUE TO THE USE OF A NON QUALIFIED VISCOELASTIC. MATERIAL PROPERTIES OF NONQUALIFIED VISCOSURGICAL DEVICE (OVD) MAY CONTRIBUTE TO UNDERFILL, OVERFILL, MISFOLDING OF THE HAPTICS, OR OTHER INCONSISTENT FOLDING OUTCOMES. 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 OVERRIDE THE LENS. IF THE OPERATING ROOM TEMPERATURE IS TOO HIGH (MORE THAN 23 DEGREE CELSIUS OR 73 DEGREE FAHRENHEIT) 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. BASED ON THE RESULTS FROM THE PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. 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 HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INCORRECT DEPLOYMENT OF IMPLANT. NO CLINICAL CONSEQUENCE FOR THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437648 CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. CNA0T0 25733099 00380652393690

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown