BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 22151783 · Received June 5, 2025

    Report

    Report Number
    2028159-2025-00826
    Event Type
    Injury
    Date Received
    June 5, 2025
    Report Date
    July 2, 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
    FL, US
    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. (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

    REGULATORY REPORT ATTACHMENT WAS ATTACHED AND CORRECTED INFORMATION WAS PROVIDED IN H.11. LITERATURE ARTICLE: "DIFFERENCES IN ENERGY EXPENDITURE FOR CONVENTIONAL AND FEMTOSECOND-ASSISTED CATARACT SURGERY USING 2 DIFFERENT PHACOEMULSIFICATION SYSTEMS" (J CATARACT REFRACT SURG 2017; 43:16¿21). SPECIFIC PRODUCT IDENTIFIERS (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. 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 LITERATURE ARTICLE REVEALED THAT A PATIENT EXPERIENCED POSTERIOR CAPSULE RUPTURE AFTER CATARACT SURGERY. CURRENT CONDITION OF PATIENT IS UNKNOWN. NO FURTHER FOLLOW UP WILL BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72507 CENTURION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other LENSX LASER SYSTEM.