BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYS

    MDR report key: 3851657 · Received April 18, 2014

    Report

    Report Number
    2028159-2014-00716
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 16, 2013
    Manufacturer
    ALCON - LENSX LASERS, INC
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Product Problem
    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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE PLANNED CAPSULOTOMY DID NOT OCCURED IN THE RIGHT POSITION WHEN PERFORMING A LENSX PROCEDURE IN A PT'S EYE. THE REPORTER FELT THAT THE TREATMENT MIGHT HAVE OCCURRED IN THE ANTERIOR CHAMBER WITH NO PT HARM. THE PROCEDURE WAS STOPPED AND MANUAL CATARACT SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238486 LENSX LASER SYS OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK