BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE

    MDR report key: 22078489 · Received May 23, 2025

    Report

    Report Number
    2028159-2025-00774
    Event Type
    Injury
    Date Received
    May 23, 2025
    Report Date
    July 24, 2025
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K161794
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. LITERATURE ARTICLE: EFFICIENCY OF PHACOEMULSIFICATION HANDPIECES WITH HIGH AND LOW INTRAOCULAR PRESSURE SETTINGS. J CATARACT REFRACT SURG 2025; 51(3): 218-221. 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

    UPON FURTHER REVIEW, THE FDA PATIENT EVENT CODE ¿IRITIS-E0828¿ HAS BEEN RETRACTED FROM THE FILE, AS THIS EVENT DOES NOT PERTAIN TO THE OPHTHALMIC SYSTEM. ADDITIONAL INFORMATION RECEIVED PROVIDED IN SECTIONS H.6., AND H.11. SPECIFIC PRODUCT IDENTIFIERS (LOT NUMBER, BATCH NUMBER, AND/OR SERIAL NUMBER WERE NOT PROVIDED AND COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, ALL DEVICE HISTORY RECORDS ARE REVIEWED PRIOR TO PRODUCT RELEASE TO ENSURE THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD AND MEETS RELEASE CRITERIA. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS SERIAL NUMBER CANNOT BE PERFORMED AS THE SERIAL NUMBER IS UNKNOWN. THE SERIAL IS UNKNOWN. THEREFORE, A SERVICE HISTORY REVIEW CANNOT BE PERFORMED. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT 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

    IN A LITERATURE STUDY ARTICLE, A PHYSICIAN REPORTED AN INVESTIGATION COMPARING THE EFFICIENCIES OF TWO HANDPIECES USED AT DIFFERENT INTRAOCULAR PRESSURE (IOP) SETTINGS, ONE WITH LOW IOP (20 MM HG) AND THE OTHER WITH HIGH IOP (50 MM HG). THE RESULTS OF THE STUDY SUGGESTED THAT THE EFFICIENCIES OF BOTH HANDPIECES WERE SIMILAR, REGARDLESS OF THE IOP SETTINGS. A TOTAL OF SEVENTY-TWO EYES FROM THIRTY-SIX PATIENT'S WHO UNDERWENT CATARACT SURGERY USING AN OPHTHALMIC OPERATING SYSTEM WERE INCLUDED IN THE STUDY. POSTOPERATIVELY, THE PATIENT'S EXPERIENCED ELEVATED INTRAOCULAR PRESSURE, CORNEAL EDEMA AND IRITIS IN THE EYE (UNKNOWN). THE CURRENT CONDITION OF THE PATIENT'S WERE RECOVERED WITHIN ONE-WEEK POST-SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069920 CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other