BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 22804643 · Received August 14, 2025

    Report

    Report Number
    2028159-2025-01204
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Report Date
    November 17, 2025
    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
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.11. THE COMPANY REPRESENTATIVE WAS ABLE TO REPLICATE THE REPORTED EVENT. THE SURGICAL FOCUSING MODULE WAS REPLACED TO ADDRESS THIS ISSUE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. 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. DURING SURGERY, THERE WAS RESISTANCE OBSERVED IN THE FLAP (AFTER FLAP CREATION WITH THE LASER). THERE WAS NO PATIENT IMPACT REPORTED. THIS INVESTIGATION WILL SERVE FOR THE EVENT OCCURRENCE WITH THE RIGHT EYE. ADDITIONAL RELATED INFORMATION WAS REQUESTED BUT NONE HAS BEEN PROVIDED TO DATE. THE CREATION OF A CORNEAL FLAP IS USED IN PATIENTS UNDERGOING LASER ASSISTED IN SITU KERATOMILEUSIS SURGERY OR OTHER TREATMENT REQUIRING INITIAL LAMELLAR RESECTION OF THE CORNEA. ANATOMICAL ABNORMALITIES OR PATIENT MOVEMENT SHOULD BE ADDRESSED PRIOR TO THE USE OF THE LASER, AS THIS MAY CAUSE AN ISSUE WITH THE FLAP CREATION. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO NONCONFORMING SURGICAL FOCUSING MODULE. 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 NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM WITH FLAP RESISTANCE IN RIGHT EYE DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED WITH SAME EQUIPMENT. THERE WAS NO PATIENT AND SURGERY WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866381 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown