BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORA SYSTEM WITH VERIFEYE MESSAGING, CART

    MDR report key: 24379018 · Received February 18, 2026

    Report

    Report Number
    2028159-2026-00201
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 6, 2026
    Report Date
    May 27, 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

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.3., H.6., AND H.11. A MANUFACTURING DEVICE HISTORY RECORD (DHR) 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 WERE NO SERVICE RECORDS (RELEVANT TO THE REPORTED EVENT), FOUND. HOWEVER, THE SYSTEM WAS LAST SERVICED PRIOR TO THE REPORTED EVENT PER SERVICE RECORD. 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.

    Description of Event or Problem · 0

    A NON HEALTHCARE PROFESSIONAL REPORTED SYSTEM PROVIDED CALCULATIONS WHICH WERE OFF IN THE LEFT EYE OF THE PATIENT AS A RESULT LENS POWER CAME OUT WRONG AFTER REFRACTIVE SURGERY.THERE WAS NO PATIENT HARM AND MEDICAL INTERVENTION REPORTED ADDITIONALLY.

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED SYSTEM PROVIDED CALCULATIONS WHICH WERE OFF IN THE LEFT EYE OF THE PATIENT AS A RESULT LENS POWER CAME OUT WRONG AFTER REFRACTIVE SURGERY, POST THE PATIENT EXPERIENCED GLARES, CORNEAL EDEMA, MILD ASTIGMATISM, DRYNESS, ITCHINESS, EYE PAIN. FURTHER, THE INTRAOCULAR LENS WAS EXPLANTED. THERE WAS NO PATIENT HARM AND MEDICAL INTERVENTION REPORTED ADDITIONALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470437 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