BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 3062809 · Received April 11, 2013

    Report

    Report Number
    3008772169-2013-00028
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    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
    TN, US
    Reporter Occupation
    PHYSICIAN

    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 SURGEON REPORTED ARCUATES INCISIONS WERE PERFORATED WHEN INJECTING VISCOELASTIC INTO THE RIGHT EYE. SUTURES WERE REQUIRED TO CLOSE THE INCISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156918 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention LENSX SOFT FIT PATIENT INTERFACE| VISCOELASTIC