BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 4209548 · Received May 2, 2014

    Report

    Report Number
    3008772169-2014-00044
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 5, 2014
    Manufacturer
    ALCON LENSX INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. NO NEW INFORMATION HAS BEEN RECEIVED.(B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT FOLLOWING LASER-ASSISTED CATARACT SURGERY, THE PATIENT PRESENTED WITH EYE DRYNESS. NO OTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265497 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other