BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 11992375 · Received June 14, 2021

    Report

    Report Number
    2028159-2021-00631
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 21, 2021
    Report Date
    August 27, 2021
    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
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.10. THE MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE SYSTEM WAS EXAMINED AND WAS ABLE TO CONFIRM AND REPLICATE A DROP IN THE OVERALL SYSTEM ENERGY. THIS MAY CONTRIBUTE TO THE REPORTED EVENT OF INCOMPLETE FLAP. AS A CORRECTION, THE COMPANY SERVICE REPRESENTATIVE CLEANED THE OPTICAL SYSTEM AND THEN PERFORMED ALIGNMENT AND CALIBRATION OF THE ENERGY SYSTEM. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY.

    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 #: (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).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED CUTS WERE INCOMPLETE DURING LASER ASSISTED FLAP CREATION. LEFT LATERAL, UPPER PORTION WITHOUT CUTTING BED NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES PATIENT ONE¿S LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889183 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1