BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM (ACTIVE SENTRY)

    MDR report key: 19723068 · Received July 11, 2024

    Report

    Report Number
    2028159-2024-01014
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 12, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    UDI-DI
    00380657530571
    PMA / PMN Number
    K161794
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE EVENT CODES A1405, A0801 AND A110201 WERE REMOVED. THE COMPANY REPRESENTATIVE WAS ABLE TO REPLICATE THE REPORTED EVENT. THE HOST WAS REPLACED TO ADDRESS THE ISSUE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. 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 ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO A NON-CONFORMING HOST. 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). REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION IS PROVIDED IN H.6 AND H.11. THE EVEN CODES A1405, A0801 AND A110201 WERE ADDED. ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS H.6 AND H.11. SERVICE HISTORY WAS REVIEWED FOR THE SYSTEM. NO SERVICE RECORD RELEVANT TO THE COMPLAINT REPORTED EVENT WAS FOUND. HOWEVER, THE SYSTEM WAS LAST SERVICED PRIOR TO THE REPORTED EVENT PER SERVICE RECORD (SR) OPENED. THE SYSTEM FOUND TO MEET ALL COSMETIC AND PERFORMANCE STANDARDS AT THAT TIME. A FOLLOW UP FROM THE COMPANY REPRESENTATIVE REVEALED THAT THE EVENT OCCURRED AGAIN. WHEN THE COMPANY REPRESENTATIVE ASKED TO SCHEDULE A SYSTEM CHECK VISIT, ¿HE CUSTOMER ¿DID NOT ACCEPT FURTHER SERVICE AND REQUESTED TO REPLACE THE SYSTEM.¿ AS SUCH, THE ENTIRE SYSTEM WAS REPLACED BUT HAS NOT BEEN RETURNED FOR ADDITIONAL TESTING. BASED ON THE RESULTS OF THIS INVESTIGATION, THE REPORTED EVENT CANNOT BE CONFIRMED. 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. A POTENTIALLY RELEVANT COMPLAINT WAS FOUND AND REVIEWED AS PART OF THIS INVESTIGATION. THE POTENTIALLY RELEVANT COMPLAINT IS STILL UNDER INVESTIGATION. THEREFORE, THE ROOT CAUSE FOR RELEVANT COMPLAINT IS INCONCLUSIVE. 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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY OPHTHALMIC SYSTEM HAD BLACK SCREEN, NULL, DID NOT RECOGNIZE HANDPIECE, NO FLUID AND LOOSE TIP AND AN OPHTHALMIC HANDPIECE DID NOT WORK AND PATIENT WAS TRANSFERRED FROM EMERGENCY ROOM TO ANOTHER HEALTHCARE CENTER TO FINISH THE SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272895 CENTURION VISION SYSTEM (ACTIVE SENTRY) UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA 15LMCK 00380657530571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CENSURGICAL PAK| CVS, ACCESSORY, HANDPIECE