BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE

    MDR report key: 18054934 · Received November 2, 2023

    Report

    Report Number
    2028159-2023-01504
    Event Type
    Injury
    Date Received
    November 2, 2023
    Date of Event
    September 15, 2023
    Report Date
    September 17, 2024
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    UDI-DI
    00380657529148
    PMA / PMN Number
    K161794
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. A NON-CONFORMANCE BASED REVIEW OF THE 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 SERIAL NUMBER WAS PERFORMED. NO SIMILAR COMPLAINTS WERE REPORTED FOR THE PRODUCT SERIAL UNDER INVESTIGATION. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. 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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN SECTIONS D.4. D.9. H.3. H.6 AND H.11 THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. HOWEVER, THE PHACOEMULSIFICATION HANDPIECE E(HP) WAS RETURNED FOR TESTING ON THIS INVESTIGATION. A NON-CONFORMANCE BASED REVIEW OF THE 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 SERIAL NUMBER WAS PERFORMED. NO SIMILAR COMPLAINTS WERE REPORTED FOR THE PRODUCT SERIAL UNDER INVESTIGATION. THE HANDPIECE WAS RECEIVED FOR TESTING ON THIS INVESTIGATION. A VISUAL ASSESSMENT OF THE RETURNED SAMPLE REVEALED NO OBVIOUS NONCONFORMITY. THE HANDPIECE WAS CONNECTED TO A CALIBRATED RESISTANCE TEST BOX, WHERE THE INPUT AND OUTPUT IMPEDANCE, RESISTANCE, AND DISSIPATION WERE FOUND TO BE WITHIN SPECIFICATION. THE RETURNED SAMPLE WAS CONNECTED TO A CALIBRATED SYSTEM. THE HANDPIECE TUNED SUCCESSFULLY AND COMPLETED A FIVE-MINUTE BURN-IN TEST WITH THE SYSTEM SET AT 100% ULTRASONIC AND TORSIONAL POWER. THE HANDPIECE WAS CONNECTED TO DYNAMIC TUNING FIXTURE (DTF) FOR STROKE LENGTH TESTING ON THE LONGITUDINAL AND TORSIONAL MOVEMENTS WHICH FOUND THE HANDPIECE TO MEET SPECIFICATIONS. THE HANDPIECE WAS FOUND TO MEET SPECIFICATIONS. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. 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 DURING THE CATARACT SURGERY THE OPHTHALMIC OPERATING HANDPIECE USED AND DISPLAYED AND ERROR CODE AND THE PATIENT EXPERIENCED THE EVENT NUCLEUS DROPPED DUE TO THE SUDDEN IRRIGATION DROP FOR WHICH VIT-RETINAL WAS PERFORMED AS SURGICAL INTERVENTION. THE SURGERY WAS COMPLETED WITH HELP OF THE SAME HANDPIECE. THE CURRENT OUTCOME OF THE PATIENT CONDITION WAS NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009082 CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA 15A37H 00380657529148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R