BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM

    MDR report key: 22320215 · Received June 24, 2025

    Report

    Report Number
    9612169-2025-01279
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    May 20, 2025
    Report Date
    July 23, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652398329
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN B2 AND B5. CORRECTION INFORMATION PROVIDED IN G3 AND H11. ON INITIAL MEDICAL DEVICE REPORT (MDR) THE G3 DATE WAS AN ERROR. THE G3 DATE SHOULD HAVE BEEN 30-MAY-2025 INSTEAD OF 29-MAY-2025. THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT CNA0T3-T9 THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # P190018). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED DUE TO UNSPECIFIED COMPLICATIONS AND A VITRECTOMY WAS PERFORMED. THE LENS WAS NOT DAMAGED. ADDITION INFORMATION WAS REQUESTED AND NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE CANNULA FLEW OFF THE SYRINGE AND RIPPED THE CAPSULE (CAPSULAR TEAR). IT WAS ALSO REPORTED THAT; AN UNPLANNED VITRECTOMY PROCEDURE WAS PERFORMED. THE LENS WAS NOT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999207 CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNA0T2 25905328 00380652398329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention