BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 12375063 · Received August 26, 2021

    Report

    Report Number
    2028159-2021-00949
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Report Date
    October 26, 2021
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    UDI-DI
    00380657530410
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN SECTION B.5 AND E.1. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE COMPANY REPRESENTATIVE PROVIDED A PHONE FIX FOR THE CUSTOMER. THE ISSUE WAS CAUSED BY USER ERROR. THE COMPANY REPRESENTATIVE DISCOVERED THAT THE NEW TECH AT THE CUSTOMER SITE DID NOT KNOW HOW TO USE THE SYSTEM CORRECTLY. THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO USER ERROR. MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PREVIOUSLY REPORTED INDICATED THAT THE OPERATING ROOM TECHNICIAN WAS NEW AND DID NOT OPERATE THE CONSOLE CORRECTLY.

    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 HEALTH PROFESSIONAL REPORTED THAT TABLE TOP BULB DID NOT ILLUMINATE ON OPHTHALMIC OPERATING CONSOLE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272179 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA NA 00380657530410

    Patients

    Seq Age Sex Outcome Treatment
    1