BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 3024763 · Received March 25, 2013

    Report

    Report Number
    3008772169-2013-00021
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    April 1, 2011
    Report Date
    February 25, 2013
    Manufacturer
    ALCON - LENSX LASERS, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    BASED ON THE ATTACHED PUBLISHED ARTICLE: 2013 BY THE AMERICAN ACADEMY OF OPHTHALMOLOGY PUBLISHED BY ELSEVIER INC, "SURGICAL OUTCOMES AND SAFETY OF FEMTOSECOND LASER CATARACT SURGERY: A (B)(4) STUDY OF 1500 CONSECUTIVE CASES", COMPLICATIONS WERE NOTED FOR THE (B)(4) SUBJECTS INVOLVED. THIS REPORT FOLLOWS THE FOUR POSTERIOR CAPSULAR RUPTURE AND VITREOUS LOSS. ADDITIONAL REPORTS WILL BE PROVIDED FOR OTHER EVENTS NOTED IN THE ARTICLE. PLEASE REFER TO THE ARTICLE FOR ADDITIONAL DETAILS REGARDING THE RESULTS OF THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121999 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention