BEUDAMED
    FDA Adverse Event Other Summary report: N

    LENSAR LASER SYSTEM -FS 3D

    MDR report key: 3772119 · Received April 9, 2014

    Report

    Report Number
    3009026057-2014-00004
    Event Type
    Other
    Date Received
    April 9, 2014
    Date of Event
    February 17, 2014
    Report Date
    April 1, 2014
    Manufacturer
    LENSAR INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT FILES WERE REVIEWED AND IT WAS EASY TO SEE THAT THE WRONG BED ORIENTATION WAS SELECTED FOR THREE PTS IN A ROW. THE BED AND SURGEON ORIENTATION WILL REMAIN THE SAME AS THE PREVIOUS SURGERY UNLESS THE TECHNICIAN MAKES A CHANGE, IN THIS CASE THE CHANGE WAS MADE GOING FROM THE LEFT EYE TO THE RIGHT AND AT THE SAME TIME THE CORRECT BED ORIENTATION WAS ALSO SELECTED.

    Description of Event or Problem · 1

    DOCTOR REPORTED TO A LENSAR CLINICAL APPLICATION SPECIALIST ON FEB. (B)(6) 2014 THAT WHILE ON PHACO/SURGERY PAGE FOR A PT, HE NOTICED THE SCREEN ORIENTATION THAT SHOWS NASAL/TEMPORAL WAS NOT AT 0 AND 180 AXIS. IT WAS AT 90 AND 270 AXIS. HE STATES THAT HE ATTEMPTED TO CORRECT IT BY PIVOTING IT TO WHAT HE BELIEVES WAS 0 AND 180. HE THEN PLACED HIS ARCS. WHEN PT WAS UNDER MICROSCOPE, HE NOTICED THE ARCS WERE CUT IN THE WRONG AXIS AND IT WAS 90 DEGREES AWAY FROM WHAT WAS PLANNED. THIS WAS A LEFT EYE. THE NEXT 2 PTS WERE LEFT EYES (OS) AND HE HAD THE SAME ISSUES, BUT HE DID NOT PERFORM ANY ARCS ON THESE PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214201 LENSAR LASER SYSTEM -FS 3D LENSAR LASER SYSTEM -FS 3D OOE LENSAR INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other