BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 11752212 · Received April 30, 2021

    Report

    Report Number
    2028159-2021-00432
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    December 1, 2020
    Report Date
    July 16, 2021
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    UDI-DI
    00380659981623
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE NO TECHNICAL SERVICES REQUESTED OR PERFORMED RELATED TO THE REPORTED EVENT. THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED A PATIENT WITH CAPSULE TORE RESULTED IN UNPLANNED VITRECTOMY. VITREOUS LEAK WAS REPORTED TO BE OBSERVED DURING HYDRO DISSECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652870 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LENSX LASER SYSTEM| LENSX LASER SYSTEM