BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 18864109 · Received March 8, 2024

    Report

    Report Number
    2028159-2024-00389
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    January 5, 2024
    Report Date
    March 14, 2024
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    OOE
    UDI-DI
    00380659981623
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW THIS COMPLAINT WAS REASSESSED AND CONFIRMED THAT, THIS EVENT DOES NOT MEET CRITERIA FOR REPORTING AS A REPORTABLE MALFUNCTION AS THE SYSTEM UNABLE TO COMPLETE PROCEDURE IN THE UNKNOWN EYE OF A PATIENT, DURING SURGERY. NO FURTHER REGULATORY REPORTS REQUIRED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. ALCON LENSX (SITE #3008772169) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. IRVINE TECHNOLOGY CENTER SITE #2028159). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM WAS UNABLE TO COMPLETE THE PROCEDURE DURING LASIK PROCEDURE IN THE UNKNOWN EYE OF A PATIENT. A NEW PATIENT INTERFACE WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882159 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female LENSX LASER SYSTEM, PATIENT INTERFACE