BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORA SYSTEM 2000

    MDR report key: 10233543 · Received July 6, 2020

    Report

    Report Number
    2028159-2020-00488
    Event Type
    Injury
    Date Received
    July 6, 2020
    Report Date
    October 9, 2020
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    NCF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT. THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE IS LIKELY DUE TO SURGICAL/CLINICAL FACTORS, UNRELATED TO DEVICE FUNCTIONALITY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    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).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED A PATIENT WITH RESIDUAL ASTIGMATISM FOLLOWING ABERROMETRY ASSISTED CATARACT SURGERY. AFTER SEVERAL MEASUREMENTS, THE DOCTOR IMPLANTED THE ABERROMETRY SUGGESTED INTRAOCULAR LENS. THE PATIENT UNDERWENT AN EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697755 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention