BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 22369035 · Received July 1, 2025

    Report

    Report Number
    2028159-2025-00955
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    April 10, 2025
    Report Date
    July 1, 2025
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    UDI-DI
    00380659981623
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A MANUFACTURING DEVICE HISTORY RECORD 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. THE COMPANY REPRESENTATIVE WAS ABLE TO REPLICATE THE REPORTED EVENT. THEREFORE, THE NONCONFORMING OSCILLATOR WAS REPLACED TO ADDRESS THE ISSUE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO NONCONFORMING OSCILLATOR. 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 PROCEDURE WAS INTERRUPTED WITH INCOMPLETE SIDE CUT AND THE PROCEDURE WAS ABORTED IN UNKNOWN EYE OF THE PATIENT DURING LASIK SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261597 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Required Intervention