BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM

    MDR report key: 19497004 · Received June 10, 2024

    Report

    Report Number
    9612169-2024-00534
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Report Date
    August 28, 2024
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652393805
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    CORRECTION: ON INITIAL MDR THE PRODUCT CODE OF A1501 WAS AN ERROR. IT SHOULD HAVE BEEN A050301 ON THE ORIGINAL MDR. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. BASED ON THE RESULTS FROM THE PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE THE PLUNGER DID NOT STOP PUSHING THE IOL AND IT CAME OUT OF THE CARTRIDGE COMPLETELY. THE DOCTOR MOUNTED THE IOL IN A MONARCH CARTRIDGE AND PROCEEDED TO IMPLANT IT IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148551 CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. CNA0T0 25460420 00380652393805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown