BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORA SYSTEM 2000

    MDR report key: 19739076 · Received July 15, 2024

    Report

    Report Number
    2028159-2024-01023
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    January 16, 2024
    Report Date
    October 23, 2024
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    NCF
    UDI-DI
    00380657530014
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 AN EXPLANTED INTRAOCULAR LENS DUE TO A MYOPIC REFRACTIVE OUTCOME WAS GREATER THAN TWO DIOPTERS IN THE PATIENT'S UNKNOWN EYE AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258583 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU 00380657530014

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other CLAREON VIVITY EXTENDED UV IOL.| REPLACED WITH ATIOL.