BEUDAMED
    FDA Adverse Event Other Summary report: N

    LENSAR LASER SYSTEM -FS 3D

    MDR report key: 3908582 · Received June 11, 2014

    Report

    Report Number
    3009026057-2014-00009
    Event Type
    Other
    Date Received
    June 11, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 11, 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

    FROM THE INVESTIGATION OF THE RTF FILE, IT SHOWED THAT THE BED ORIENTATION SELECTED WAS 'BED RIGHT" INSTEAD OF "BED CENTER." A CONFERENCE CALL WAS HELD WITH THE DOCTOR AND HE UNDERSTOOD THAT BY SELECTING THE WRONG BED ORIENTATION, THE RESULT WAS THAT HIS CORNEAL TREATMENT WAS PLACED ON THE WRONG AXIS. THIS IS AN OPERATOR ERROR.

    Description of Event or Problem · 1

    DOCTOR REPORTED TO A LENSAR CLINICAL APPLICATION SPECIALIST THAT ON (B)(6) 2014 A CCI WAS PLACED IN THE WRONG POSITION. WHEN THE DOCTOR LOOKED AT THE RTF FILE, IT SHOWED THAT THE ORIENTATION SELECTED WAS "BED RIGHT" INSTEAD OF "BED CENTER." HE UNDERSTOOD THAT BY SELECTING THE WRONG BED ORIENTATION, THE RESULT WAS THAT HIS CORNEAL TREATMENT WAS PLACED ON THE WRONG AXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346193 LENSAR LASER SYSTEM -FS 3D LENSAR LASER SYSTEM -FS 3D OOE LENSAR INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other