BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 22034702 · Received May 16, 2025

    Report

    Report Number
    2028159-2025-00725
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    May 8, 2025
    Report Date
    August 7, 2025
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Removal / Correction Number
    NA
    Adverse Event
    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

    ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS D.9, H.3, H.6 AND H.11. THE COMPANY REPRESENTATIVE WAS UNABLE TO CONFIRM NOR REPLICATE ANYTHING THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 WITH THE SAME EVENT CODE. THE SYSTEM 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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS B.2, B.5, E.1 AND H.6. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT A PATIENT EXPERIENCED MACULAR EDEMA AFTER USING AN OPHTHALMIC SYSTEM FOR CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. OUTCOME OF THE PATIENT WAS UNKNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LEFT EYE WAS AFFECTED, AND MACULAR EDEMA WAS OBSERVED FORTY-SEVEN DAYS AFTER SURGERY. AN OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED AT THAT TIME. EIGHT DAYS AFTER THE OBSERVATION, A CORTICOSTEROID DRUG WAS INJECTED INTO THE TENON¿S SAC, AND THE INJECTION OF ANTIANGIOGENIC AGENTS INTO THE VITREOUS CAVITY WAS CONSIDERED AS A MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217061 CENTURION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O