BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORA SYSTEM 2000

    MDR report key: 6947345 · Received October 13, 2017

    Report

    Report Number
    2028159-2017-04053
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    September 20, 2017
    Report Date
    January 18, 2018
    Manufacturer
    ALCON RESEARCH, LTD. - 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
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY CLINICAL APPLICATION SPECIALIST (CAS) PROVIDED FEEDBACK ON THE REVIEW OF THIS CASE. PER PATIENT DATA ANALYSIS, IT CANNOT BE DETERMINED IF THE SURGEON PERFORMED ADEQUATE PRELIMINARY CALCULATIONS OR IF THE SURGEON WENT WITH THE ABERROMETER RECOMMENDATION DURING THE PROCEDURE. THE PATIENT¿S PRE-EXISTING CONDITION OF MILD BASE MEMBRANE DYSTROPHY IS A POTENTIAL CONTRIBUTING FACTOR. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. (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 SURGEON REPORTED AN UNEXPECTED REFRACTIVE OUTCOME POST ABERROMETER ASSISTED CATARACT PROCEDURE OF THE RIGHT EYE. REPORTER INDICATED HE WILL EITHER NEED TO REPOSITION OR REPLACE THE IMPLANTED INTRAOCULAR LENS (IOL), AS A RESULT OF GOING WITH THE ABERROMETER SUGGESTED IOL. ADDITIONAL INFORMATION RECEIVED INDICATES THE SURGEON PERFORMED AN IOL ROTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727622 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other (B)(4). SN:(B)(4)