BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORA SYSTEM WITH VERIFEYE MESSAGING

    MDR report key: 19642555 · Received July 1, 2024

    Report

    Report Number
    2028159-2024-00949
    Event Type
    Injury
    Date Received
    July 1, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    NCF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    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. ALL DEVICE HISTORY RECORDS ARE REVIEWED PRIOR TO PRODUCT RELEASE TO ENSURE THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD AND MEETS RELEASE CRITERIA. 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 HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM WITH INACCURATE MEASUREMENTS AND INTRAOCULAR LENS WAS EXPLANTED DUE TO PATIENT HAD ASTIGMATISM IN RIGHT EYE OF A PATIENT. THE LENS WAS REPLACED WITH ADVANCED TECHNOLOGY INTRAOCULAR LENS. THE SURGEON TOOK THE READING, AND THE MEASUREMENT WAS MISLEADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816656 ORA SYSTEM WITH VERIFEYE MESSAGING ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention CLAREON MONARCH IV IOL.| CLAREON PANOPTIX LENS.| CLAREON PANOPTIX TORIC IOL.| MONARCH II FORCEPS.| MONARCH III IOL SYSTEM.| ORA WITH VERIFEYE, CART.| PROVISC OPHTHALMIC DEVICE.