BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 4132816 · Received September 29, 2014

    Report

    Report Number
    3008772169-2014-00132
    Event Type
    Injury
    Date Received
    September 29, 2014
    Report Date
    September 2, 2014
    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
    GM
    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 INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE CAPSULOTOMY WAS OVAL (INSTEAD OF CIRCULAR), THE CAPSULE WAS NOT COMPLETELY DISSECTED AND A CAPSULE RUPTURE OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606959 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other