BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 6053548 · Received October 25, 2016

    Report

    Report Number
    3008772169-2016-00699
    Event Type
    Injury
    Date Received
    October 25, 2016
    Date of Event
    September 28, 2016
    Report Date
    December 19, 2016
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO TECHNICAL SERVICES WERE REQUESTED OR PERFORMED ON THE SYSTEM. BASED ON QUALITY ASSESSMENT, 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. (B)(4).

    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).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A POSTERIOR CAPSULE HOLE OCCURRED IN THE RIGHT EYE AND WAS NOTICED AFTER SCULPTING AND WHILE REMOVING THE LAST SEGMENT OF THE CAPSULE AFTER THE LASER PORTION OF A LASER ASSISTED CATARACT PROCEDURE. ALTHOUGH NO VITREOUS WAS NOTED IN THE ANTERIOR CHAMBER, AN ANTERIOR VITRECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706055 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention