BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORA SYSTEM 2000

    MDR report key: 10860263 · Received November 18, 2020

    Report

    Report Number
    2028159-2020-00990
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Report Date
    May 19, 2021
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    NCF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND THE ABERROMETER OPTIC DISLODGED. THE COMPANY SERVICE REPRESENTATIVE REPLACED THE ABERROMETER. THE COMPANY SERVICE REPRESENTATIVE ALIGNED THE SYSTEM TO THE MICROSCOPE AND ALIGNED THE RETICLE TO SLED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ABERROMETER WAS RECEIVED AND A VISUAL ASSESSMENT OF THE RETURNED SAMPLE REVEALED A LOOSE OPTIC WITHIN THE ABERROMETER. THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY ATTRIBUTED TO CUSTOMER USE/HANDLING. HOWEVER, THIS WAS UNABLE TO BE DETERMINED, AS HOW OR WHEN THE OPTICS BECAME LOOSE REMAINS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED CONCLUSIVELY. 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. (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED DURING INTRAOPERATIVE ABBEROMETRY ASSISTED CATARACT SURGERY THE SYSTEM SUGGESTED A 13 DIOPTER INTRAOCULAR LENS (IOL) AND THE PRE-OPERATIVE PLANNED IOL WAS 19 DIOPTERS. ADDITIONAL INFORMATION FROM THE SITE STATED THE SURGEON WENT WITH THE PRE-OPERATIVE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330502 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1