BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORA SYSTEM WITH VERIFEYE MESSAGING, CART

    MDR report key: 20803352 · Received November 28, 2024

    Report

    Report Number
    2028159-2024-01860
    Event Type
    Injury
    Date Received
    November 28, 2024
    Date of Event
    October 11, 2024
    Report Date
    February 16, 2025
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    NCF
    UDI-DI
    00380657530939
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    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 IS NO SERVICE RECORD RELEVANT TO THE REPORTED EVENT FOUND. HOWEVER, THE SYSTEM WAS LAST SERVICED PRIOR TO THE REPORTED EVENT PER SERVICE RECORD OPENED. THE SYSTEM FOUND TO MEET ALL COSMETIC AND PERFORMANCE STANDARDS. 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.

    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.

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT SYSTEM WITH INACCURATE LENS RECOMMENDATION RESULTED IN UNEXPECTED OUTCOMES AND EXPLANT OF THE INTRAOCULAR LENS IN THE LEFT EYE OF A PATIENT, AND PATIENT EXPERIENCED EYE IRRITATED, BLURRY ALL THE TIME AND HURTS WITH THE POST OPERATIVE BEST CORRECTED VISUAL ACUITY VALUES WERE MORE THAN ONE DIOPTER AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2613258 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 65 YR Female Required Intervention| O