BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORA SYSTEM WITH VERIFEYE MESSAGING

    MDR report key: 20469182 · Received October 17, 2024

    Report

    Report Number
    2028159-2024-01575
    Event Type
    Injury
    Date Received
    October 17, 2024
    Date of Event
    July 2, 2024
    Report Date
    December 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
    MI, US
    Reporter Occupation
    003

    Narratives

    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.

    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 FOLLOWING AN INTRAOCULAR LENS IMPLANT, THE PATIENT WAS UNABLE TO TOLERATE THE MULTIFOCAL LENS. THE PATIENT EXPERIENCED SIGNIFICANT GLARE IN THE LEFT EYE, ALONG WITH DISCREPANCIES IN THE INTRAOCULAR LENS CALCULATIONS IN THE SYSTEM, WHICH RESULTED IN AN UNEXPECTED HYPEROPIC OUTCOME AFTER CATARACT SURGERY. ADDITIONALLY, THE PATIENT REPORTED ISSUES WITH GLARE, HEADACHES, AND NAUSEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368092 ORA SYSTEM WITH VERIFEYE MESSAGING ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other| R CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.| CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL.| CLAREON TORIC IOL.| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.