BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2881569 · Received December 17, 2012

    Report

    Report Number
    3008772169-2012-00049
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ALCON - LENSX LASERS, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED INCIDENT. THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM. TO ADDRESS THE ISSUE, THE GANTRY MOTOR WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET SPECIFICATIONS. THE GANTRY MOTOR HAS BEEN RECEIVED BY THE MANUFACTURER, BUT THE EVALUATION IS NOT COMPLETE. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH THE 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CLINIC DIRECTOR REPORTED THAT DURING SURGERY THERE WAS AN OCT SYSTEM MESSAGE. TO CLEAR THE MESSAGE, THEY REBOOTED THE SYSTEM, AND DURING THE REBOOT, THE GANTRY WENT DOWN AND CONTACTED THE PT'S EYE AND FACE. THE TECHNICIAN IMMEDIATELY LOWERED THE PT BED, AND THE PT WAS NOT INJURED, AS CONFIRMED BY SLIT LAMP EXAM. THE SURGEON ALSO SAW THE PT THE NEXT DAY; THERE WAS NO SIGN OF VISIBLE INJURY, AND NO IMPACT TO THE VISUAL ACUITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention