BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 16364225 · Received February 13, 2023

    Report

    Report Number
    2028159-2023-00178
    Event Type
    Injury
    Date Received
    February 13, 2023
    Date of Event
    January 18, 2023
    Report Date
    April 3, 2023
    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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.3., H.6., AND H.10. A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. SERVICE HISTORY WAS REVIEWED FOR THE SYSTEM. THERE WAS NO SERVICE RECORD (RELEVANT TO THE REPORTED EVENT), FOUND. HOWEVER, THE SYSTEM WAS LAST SERVICED PRIOR TO THE REPORTED EVENT PER SERVICE RECORD (SR). THE SYSTEM FOUND TO MEET ALL COSMETIC AND PERFORMANCE STANDARDS. A POTENTIALLY RELEVANT COMPLAINT WAS FOUND AND REVIEWED AS PART OF THIS INVESTIGATION. THE COMPLAINT WAS DETERMINED TO NOT BE RELEVANT TO THIS INVESTIGATION. 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

    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 TEAR/DEFECT IN BOWMAN¿S LAYER OF CORNEA THAT HAPPENED SHORTLY AFTER APPLYING SUCTION AND SPREAD SLOWLY ACROSS THE CENTER OF THE CORNEA IN LEFT EYE OF A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648145 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other