BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 9925593 · Received April 3, 2020

    Report

    Report Number
    2028159-2020-00317
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    March 10, 2020
    Report Date
    April 21, 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
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.3, H.6 AND H.10. THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    ALCON LENSX (SITE (B)(4)) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. IRVINE TECHNOLOGY CENTER (SITE (B)(4)). 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 HEALTH PROFESSIONAL REPORTED EXPERIENCING BIG DIFFICULTIES DOCKING AND APPLYING SUCTION PRIOR TO CORNEAL FLAP CREATION OF THE LEFT EYE. AFTER SEVERAL ATTEMPTS SUCTION WAS ACHIEVED BUT IT WAS EVIDENT THAT THE DOCK WAS DECENTRALIZED WITH LIQUID IN THE PERIPHERY. THE SURGEON WAS ADVISED AGAINST PROCEEDING BUT CONTINUED WITH FLAP CREATION. THE FLAP WAS INCOMPLETE HOWEVER THE PROCEDURE WAS COMPLETED THE SAME DAY. IN THE SURGEONS OPINION IT IS UNKNOWN WHAT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER INFORMATION CAN BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387943 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR