BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM (ACTIVE SENTRY)

    MDR report key: 14209800 · Received April 26, 2022

    Report

    Report Number
    2028159-2022-00568
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    March 31, 2022
    Report Date
    August 22, 2022
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    UDI-DI
    00380657530571
    PMA / PMN Number
    K161794
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Additional Manufacturer Narrative · 0

    THE COMPANY REPRESENTATIVE CONFIRMED AND REPLICATED THE REPORTED EVENT(S). IT WAS DETERMINED WITH THE BALANCED SALT SOLUTIONS (BSS) GET LOW THE BUSSING NOISES OCCUR. ADDITIONALLY, TO ADDRESS THE ISSUE WITH THE OSCILLATION ISSUE, THE CABLE ASSEMBLY WAS SUBSEQUENTLY REPLACED TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. A NON-CONFORMANCE-BASED REVIEW OF THE BATCH/LOT/SERIAL NUMBER WAS PERFORMED AND DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT. A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT/BATCH/SERIAL NUMBER WAS PERFORMED. NO SIMILAR COMPLAINTS WERE REPORTED FOR THE PRODUCT LOT/BATCH/SERIAL UNDER INVESTIGATION. THE ROOT CAUSE OF THE ¿BUZZING NOISE¿ IS ATTRIBUTED TO LOW BSS. THE ROOT CAUSE OF THE DISABLED U/S OSCILLATION IS ATTRIBUTED TO A NONCONFORMING CYLINDER IN THE AI CABLE. 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

    A PHYSICIAN REPORTED THAT AN OPHTHALMIC OPERATING CONSOLE PRESENTED NO ULTRASOUND OSCILLATION DURING A SURGERY. A STRANGE NOISE WAS HEARD FROM THE CONSOLE. THE PROBLEM WAS RESOLVED BY REPLACING THE HANDPIECE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT HARM. ADDITIONAL INFORMATION CANNOT BE OBTAINED AS THE REPORTED IS UNWILLING TO FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513460 CENTURION VISION SYSTEM (ACTIVE SENTRY) UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA 13948N 00380657530571

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown