BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 3763435 · Received April 9, 2014

    Report

    Report Number
    3008772169-2014-00033
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 9, 2014
    Report Date
    March 10, 2014
    Manufacturer
    ALCON - LENSX LASERS, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 A CASE OF ENDOPHTHALMITIS, OBSERVED ON A PT'S LEFT EYE AT FOUR DAYS POST LASER ASSISTED CATARACT PROCEDURE. REPORTER INDICATED THE PT HAD "TRACE/1+" LIMBAL INJECTION AND THE CORNEA HAD A GROUND GLASS APPEARANCE. ADDITIONALLY, FIBRIN WAS NOTED FROM PARACENTESIS TO PUPIL MARGIN AT TEN O'CLOCK POSITION, THE WOUND WAS INTACT WITHOUT INFILTRATE, VERTICAL ENDOTHELIAL FOLDS PRESENT, LESS THAN FIVE PERCENT HYPOPYON WERE PRESENT, AND NO CULTURES WERE TAKEN. REPORTER ALSO INDICATED THE PT WAS REFERRED TO A RETINAL SPECIALIST, WHERE A FULL VITRECTOMY WAS PERFORMED. PT COMPLAINED OF DECREASED VISION, AND NO PAIN OR DISCHARGE WAS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214062 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INFINITI VISION SYSTEM OZIL