BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 3951844 · Received July 2, 2014

    Report

    Report Number
    3008772169-2014-00074
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 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
    SD, 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 ADDITION REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AT THE END OF LASER ASSISTED CATARACT SURGERY, SHE OPENED THE ARCUATE INCISIONS, AND ONE OF THEM PERFORATED THE CORNEA. A SUTURE WAS PLACED TO CLOSE THE WOUND. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON INDICATED THAT THE EVENT RESOLVED WITH THE TREATMENT (SUTURE PLACED). IN THE OPINION OF THE SURGEON, THE LASER DID NOT CAUSE OF CONTRIBUTE TO THE EVENT. NO FURTHER INFORMATION IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386219 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention