BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 19794143 · Received July 22, 2024

    Report

    Report Number
    2028159-2024-01069
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    June 26, 2024
    Report Date
    October 18, 2024
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    UDI-DI
    00380659981623
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.11. 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 UNABLE TO CONFIRM NOR REPLICATE THE REPORTED EVENT. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. THE CUSTOMER REPORTED EVENT CANNOT BE CONFIRMED. THUS, BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    H.3., H.6.: 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 CUSTOMER REPORTED THAT THE MACHINE FAILED TO COMPLETELY CUT THE PATIENT'S MAIN AND SIDE PORTS IN AN UNSPECIFIED EYE, DURING A FLAP CREATION PROCEDURE. THE INCOMPLETE INCISIONS HAD TO BE MANUALLY COMPLETED WITH A KNIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119418 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention