BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 3884071 · Received June 9, 2014

    Report

    Report Number
    3008772169-2014-00068
    Event Type
    Injury
    Date Received
    June 9, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ALCON - LENSX LASERS, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. THE FIELD SERVICE ENGINEER (FSE) CHECKED THE LASER SYSTEM, BUT DID NOT FIND ANY ISSUE WITH THE SYSTEM. NO PROBLEM WAS FOUND. THE LASER SYSTEM WAS WITHIN SPECIFICATIONS PRIOR TO THE FSE DEPARTURE. NO TESTING WAS PERFORMED AS NO PARTS WERE RETURNED. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON THE COMPANY'S ACCEPTANCE CRITERIA. NO PROBLEM WAS FOUND WITH THE LASER SYSTEM. THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 06/11/2014. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED SUCTION LOSS DURING FRAGMENTATION PORTION OF LASER ASSISTED CATARACT PROCEDURE. THERE WAS AN ANTERIOR CAPSULE TEAR THAT REQUIRED A VITRECTOMY PROCEDURE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334503 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention