BEUDAMED
    FDA Adverse Event Other Summary report: N

    LENSAR LASER SYSTEM - FS 3D

    MDR report key: 3772257 · Received March 27, 2014

    Report

    Report Number
    3009026057-2014-00003
    Event Type
    Other
    Date Received
    March 27, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 27, 2014
    Manufacturer
    LENSAR INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A DOCTOR REPORTED TO A LENSAR CLINICAL APPLICATION SPECIALIST ON (B)(6) 2014 THAT DURING A LASER TREATMENT ON (B)(6) 2014, THE PT MOVED AND SUCTION WAS LOST. LASER COMPLETED ONLY 21%. UNDER THE MICROSCOPE, THE DOCTOR CONFIRMED THAT THE CAPSULOTOMY WAS COMPLETED BY LASER BUT IT APPEARED THAT THE CORNEA HAD THE FRAGMENTATION PATTERN ETCHED ON IT. CATARACT SURGERY WAS COMPLETED MANUALLY WITH NO ADD'L TREATMENT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182624 LENSAR LASER SYSTEM - FS 3D LENSAR LASER SYSTEM - FS 3D OOE LENSAR INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other