BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 8315370 · Received February 7, 2019

    Report

    Report Number
    2028159-2019-00196
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    January 21, 2019
    Report Date
    April 12, 2019
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    OOE
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. 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 · 0

    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

    FOLLOW UP INFORMATION RECEIVED INDICATED THE PROCEDURE WAS CANCELED. THERE WAS NO PATIENT HARM.

    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 NURSE REPORTED THE DOCTOR WAS UNABLE TO LIFT THE FLAP BECAUSE THE CUT WAS NOT GOOD FOLLOWING FLAP CREATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111657 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1