BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 10255311 · Received July 9, 2020

    Report

    Report Number
    2028159-2020-00503
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    June 19, 2020
    Report Date
    August 20, 2020
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION PROVIDED IN G.1, G.2 AND H.10. 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

    ADDITIONAL INFORMATION PROVIDED IN D.10, H.3, H.6, AND H.10. FOLLOWING THE REPORTED EVENT, A SERVICE REQUEST (SR) WAS OPENED FOR STANDARD PREVENTATIVE MAINTENANCE (PM). THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO CONFIRM OR REPLICATE ANY SYSTEM NONCONFORMITY, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE SYSTEM WAS FOUND TO MEET SPECIFICATIONS; THEREFORE, 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN UNSATISFACTORY RESULT FOLLOWING CORNEAL FLAP CREATION. THE SITE REPORTS DIFFICULT TO DOCK AND MULTIPLE DOCKS. THE FLAP WAS REPORTED AS THICK AND DIFFICULT TO LIFT. ADDITIONAL INFORMATION IS REQUESTED. THERE ARE MULTIPLE REPORTS FOR THIS EVENT; THIS FILE REPRESENTS PATIENT TWO LEFT EYE AND ADDITIONAL REPORTS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720073 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LENSX PATIENT INTERFACE-10/BOX, 8065998163, LENSX