BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 6098272 · Received November 13, 2016

    Report

    Report Number
    3008772169-2016-00769
    Event Type
    Injury
    Date Received
    November 13, 2016
    Date of Event
    October 17, 2016
    Report Date
    January 18, 2017
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    NO TECHNICAL SERVICES WERE REQUESTED OR PERFORMED ON THE SYSTEM DUE TO THE REPORTED EVENT. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED SHE WAS UNABLE TO SEAL THE PRIMARY INCISION AT THE END OF HER LAST CASE FOR LASER ASSISTED CATARACT PROCEDURE. SURGEON INDICATED SHE NOTICED THE INTEGRITY OF THE ROOF OF THE PRIMARY INCISION WAS A BIT RAW. SHE PLACED A SUTURE IN THE PRIMARY INCISION OF THE LEFT EYE TO SEAL IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749433 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention