BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 6974628 · Received October 24, 2017

    Report

    Report Number
    3008772169-2017-00524
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    September 28, 2017
    Report Date
    January 2, 2018
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED ADHESIONS ON TEN PERCENT OF THE FLAP FOLLOWING CORNEAL FLAP CREATION. THE SURGEON WAS ABLE TO PEEL THROUGH WITH A HOOK. FOLLOWING THE PROLONGED AND EXCESSIVE MANIPULATION THE CORNEAL EPITHELIUM SLOUGHED OFF. A BANDAGE CONTACT LENS WAS PLACED. THE FOLLOWING DAY THE PATIENT WAS DOING WELL POST OPERATIVELY. THE SURGEON ADDITIONALLY REPORTS THAT THE PATIENTS EPITHELIUM ADHERENCE WAS COMPROMISED PREOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750345 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other