BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 18526563 · Received January 17, 2024

    Report

    Report Number
    2028159-2024-00093
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    December 18, 2023
    Report Date
    March 14, 2024
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    UDI-DI
    00380659981623
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

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

    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 OPAQUE AREA OR ACCUMULATION OF FLUID UNDER PATIENT INTERFACE IN THE UNKNOWN EYE, DURING THE TREATMENT. NO FURTHER REGULATORY REPORTS REQUIRED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE OPAQUE AREA OR ACCUMULATION OF FLUID UNDER PATIENT INTERFACE IN THE UNKNOWN EYE, DURING CATARACT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405470 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown