BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 10293499 · Received July 18, 2020

    Report

    Report Number
    2028159-2020-00546
    Event Type
    Malfunction
    Date Received
    July 18, 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

    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. 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 · 1

    A SURGEON REPORTED AN UNSATISFACTORY RESULT FOLLOWING CORNEAL FLAP CREATION OF THE LEFT EYE. THE SITE REPORTS DIFFICULT TO DOCK AND MULTIPLE DOCKS. THE FLAP WAS DECENTERED BUT SURGERY WAS CONTINUED AS THE TREATMENT AREA WAS WITHIN THE DECENTERED FLAP. ADDITIONAL INFORMATION RECEIVED; THE LEFT EYE IS RECOVERED AND NO ADDITIONAL TREATMENT WAS REQUIRED. THERE ARE MULTIPLE REPORTS FOR THIS FACILITY. THIS FILE REPRESENT PATIENT ONE LEFT EYE AND ADDITIONAL REPORTS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757359 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