BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORA SYSTEM WITH VERIFEYE MESSAGING

    MDR report key: 10492395 · Received September 4, 2020

    Report

    Report Number
    2028159-2020-00702
    Event Type
    Injury
    Date Received
    September 4, 2020
    Report Date
    December 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLINICAL APPLICATION SPECIALIST (CAS) REVIEWED THE IMAGES AND CALCULATIONS AND CONCLUDED THE CORNEA WAS NOT PRISTINE AND DEVICE WAS NOT ABLE TO GIVE REPRODUCIBLE MEASUREMENTS. THE LENS WAS TILTED AT TIME OF CAPTURE AND WAS NOT PLACED OR HAD ROTATED FROM INTENDED AXIS AFTER IMPLANTATION CAUSING RESIDUAL CYLINDER. ROTATING THE LENS BACK ON AXIS WOULD GIVE A BETTER RESULT. THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO SURGICAL/CLINICAL FACTORS UNRELATED TO THE FUNCTIONALITY OF THE DEVICE. 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 PHYSICIAN REPORTED A PATIENT WITH RESIDUAL ASTIGMATISM FOLLOWING INTRAOPERATIVE ABERROMETRY ASSISTED CATARACT SURGERY WITH TORIC INTRAOCULAR LENS IMPLANTATION (IOL). THE ABERROMETER MEASURED THE AXIS DIFFERENTLY THAN THE PRE-OPERATIVE MEASUREMENTS AND THE SURGEON USED THE INTRAOPERATIVE AXIS MEASUREMENTS. THE SURGEON IS PLANNING FOR POSSIBLE IOL ROTATION. ADDITIONAL INFORMATION RECEIVED REPORTED THE IOL WAS SUCCESSFULLY ROTATED AND REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958121 ORA SYSTEM WITH VERIFEYE MESSAGING ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other