BEUDAMED
    FDA Adverse Event Other Summary report: N

    LENSAR LASER SYSTEM -FS 3D

    MDR report key: 3234087 · Received July 16, 2013

    Report

    Report Number
    3009026057-2013-00005
    Event Type
    Other
    Date Received
    July 16, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 15, 2013
    Manufacturer
    LENSAR INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 INFO BECOMES AVAILABLE. (B) (4).

    Description of Event or Problem · 1

    THE PT HAD AN INCOMPLETE CAPSULOTOMY DURING THE SURGICAL PROCEDURE. DURING THE SCANNING PROCEDURE, WE DIDN'T OBSERVE ANYTHING ABNORMAL. THE SYSTEM DETECTED THE CORNEAL SURFACE AND ALSO THE LENS PERFECTLY. DURING THE SURGICAL PROCEDURE, THE CAS OBSERVED A DIFFERENT BUBBLES REACTION. NOBODY REPORTED TO CAS THAT THE PT HAD AN ICL LENS IMPLANTED. WHEN THE PT WAS UNDER THE SURGICAL MICROSCOPE FOR THE PHACO PROCEDURE THE SURGEON COULD SEE THAT A CERTAIN NUMBER OR LASER PULSES TO CUT THE CAPSULOTOMY WERE SHOT INTO THE ICL MATERIAL. FINALLY, THE RHEXIS, IN THE LENS, WAS APPROX 98% COMPLETE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330143 LENSAR LASER SYSTEM -FS 3D LENSAR LASER SYSTEM -FS 3D OOE LENSAR INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other