BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 21025482 · Received December 27, 2024

    Report

    Report Number
    2028159-2024-02023
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Report Date
    February 27, 2025
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION PROVIDED IN G1. ALCON LENSX (SITE #(B)(6) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. IRVINE TECHNOLOGY CENTER (SITE #(B)(6). 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).

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION PROVIDED IN G.1. PRODUCT MANUFACTURING DETAILS UPDATED. 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. THE COMPANY REPRESENTATIVE WAS ABLE TO CONFIRM THE REPORTED EVENT. THE ADJUSTMENT AND ALIGNMENT OF THE SYSTEM WAS PERFORMED TO ADDRESS THE ISSUE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO COMPONENT WEAR. HOWEVER, AS TO HOW OR WHEN THERE WAS COMPONENT WEAR REMAINS INCONCLUSIVE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM HAD RING CUTTING PROBLEMS IN THE UNKNOWN EYE OF A PATIENT, DURING CATARACT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975962 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown