BEUDAMED
    FDA Adverse Event Other Summary report: N

    LENSAR LASER SYSTEM -FS 3D

    MDR report key: 4193913 · Received October 20, 2014

    Report

    Report Number
    3009026057-2014-00026
    Event Type
    Other
    Date Received
    October 20, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 20, 2014
    Manufacturer
    LENSAR INC
    Product Code
    HQC
    PMA / PMN Number
    K120214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Description of Event or Problem · 1

    A LENSAR CLINICAL APPLICATION SPECIALIST OBSERVED AN ANTERIOR CAPSULE TEAR WHILE AT A CLINICAL SITE DUE TO AN INCOMPLETE CAPSULOTOMY. THE PATIENT HAD A SEVERE EPITHELIAL DEFECT THAT WAS NOT APPARENT UNTIL AFTER THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666682 LENSAR LASER SYSTEM -FS 3D LENSAR LASER SYSTEM -FS 3D HQC LENSAR INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other