BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 4476269 · Received May 15, 2014

    Report

    Report Number
    3008772169-2014-00054
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 18, 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
    TN, US
    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. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED PATIENT WITH SUB-INCISIONAL ANTERIOR CAPSULE TEAR OF THE RIGHT EYE AFTER FEMTOSECOND TREATMENT AND PRIOR TO IRRIGATION-ASPIRATION (I/A). ADDITIONAL INFORMATION FROM REPORTER INDICATED NO VITRECTOMY WAS PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS FOUR OF FOUR FROM FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293206 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other