BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORA SYSTEM WITH VERIFEYE MESSAGING, CART

    MDR report key: 23717795 · Received December 4, 2025

    Report

    Report Number
    2028159-2025-01797
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    October 14, 2025
    Report Date
    March 11, 2026
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    NCF
    UDI-DI
    00380657530939
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.3., H.6., AND H.11. A MANUFACTURING DEVICE HISTORY RECORD REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. SERVICE HISTORY WAS REVIEWED FOR THE SYSTEM. THERE WAS NO SERVICE (RECORD RELEVANT TO THE REPORTED EVENT), FOUND. HOWEVER, THE SYSTEM WAS LAST SERVICED PRIOR TO THE REPORTED EVENT PER SERVICE RECORD. THE SYSTEM WAS FOUND TO MEET ALL COSMETIC AND PERFORMANCE STANDARDS (AT THAT TIME). BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H.3., H.6.: 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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT EXPERIENCED RESIDUAL REFRACTION ERROR DUE TO LENS MISALIGNMENT OR DISPLACEMENT AND THE SURGEON REPORTED THAT THE SYSTEM RECOMMENDED INACCURATE MEASUREMENT. THE LENS WAS EXPLANTED AND REPLACED WITH ADVANCED TECHNOLOGY INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2744463 ORA SYSTEM WITH VERIFEYE MESSAGING, CART ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA NA 00380657530939

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other| R ANTIBIOTIC EYE DROPS.| CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.| CLAREON TORIC IOL.| CLAREON TORIC IOL.| MONARCH II LOADING FORCEPS.| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.| SINSKEY HOOK AND FORCEPS.