BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM -FS 3D

    MDR report key: 3792625 · Received January 16, 2014

    Report

    Report Number
    3009026057-2013-00020
    Event Type
    Injury
    Date Received
    January 16, 2014
    Date of Event
    December 17, 2013
    Report Date
    January 15, 2014
    Manufacturer
    LENSAR INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEVICE MALFUNCTION. THE DOCTOR STATED THAT IT WAS HIS FAULT FOR PROCEEDING. THE NUCLEUS DROPPED BACK INTO THE VITREOUS AFTER HYDRO DISSECTION AND AS HE PLACED HIS PRE-CHOPPER INTO THE NUCLEUS.

    Description of Event or Problem · 1

    A DOCTOR REPORTED TO A LENSAR CLINICAL APPLICATION SPECIALIST ON (B)(6) 2013 THAT THEY SCANNED THE PATIENT WITH AN ADVANCED CATARACT AND A SMALL PUPIL. AFTER THE SCAN, THE SYSTEM COULD NOT LOCATE POSTERIOR CAPSULE SO IT DEFAULTED TO CAP AND GROOVE FOR SAFETY. THE DOCTOR DECIDED TO RE-SCAN THE PATIENT WITH THE HOPES OF CAPTURING POSTERIOR CAPSULE. THE DOCTOR STATED THAT THE SYSTEM IDENTIFIED THE INCORRECT SURFACE, WHICH SOUNDS AS IF IT PICKED UP ON THE PUPILLARY MARGIN ON THE LAYERED IMAGE, AND SELECTED THAT AS THE POSTERIOR CAPSULE. THE DOCTOR STATED THAT IT WAS HIS FAULT FOR PROCEEDING. THE NUCLEUS DROPPED BACK INTO THE VITREOUS AFTER HYDRO DISSECTION AND AS HE PLACED HIS PRE-CHOPPER INTO THE NUCLEUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42806 LENSAR LASER SYSTEM -FS 3D LENSAR LASER SYSTEM -FS 3D OOE LENSAR INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other