BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5666011 · Received May 19, 2016

    Report

    Report Number
    3009026057-2016-00016
    Event Type
    Injury
    Date Received
    May 19, 2016
    Date of Event
    April 22, 2016
    Report Date
    June 1, 2016
    Manufacturer
    LENSAR, LLC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE RTF FILE SHOWED THAT THE TREATMENT WAS PROGRAMMED INCORRECTLY. THE CORRECT RX DATA WAS PRESENT, HOWEVER THE TORIC IOL HAD A DIFFERENT AXIS PROGRAMED. IT IS LIKELY THAT THE OPERATOR DID NOT SELECT 'USE AXIS FROM RX'. LASER LOG FILES WERE REVIEWED AND NO INDICATION OF DEVICE MALFUNCTION WAS FOUND. THE SURGICAL PROCEDURE WAS COMPLETED 100% AND NO ERROR MESSAGES WERE RECORDED. NO VITRECTOMY WAS PERFORMED. DURING A POST-OPERATIVE CLINICAL FOLLOW UP THE DOCTOR REPORTED THAT THE IOL WAS ROTATED AND NO ADDITIONAL TREATMENT WAS NECESSARY. ROOT CAUSE: USER ERROR.

    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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A DOCTOR REPORTED THAT ON ONE CASE THEY USED THE INTELLIAXIS FEATURE AND HAD SET TREATMENT FOR AN AXIS OF 102. DURING TORIC SETUP THEY THOUGHT THEY HAD SELECTED THE CORRECT TORIC LENS AND POWER SETTINGS AND CONTINUED WITH THE TREATMENT. AFTER TREATMENT THE MARKS WERE AT AXIS OF 0 AND 180 RATHER THAN 102 AND 282.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A DOCTOR REPORTED THAT ON ONE CASE THEY USED THE INTELLIAXIS FEATURE AND HAD SET TREATMENT FOR AN AXIS OF 102. DURING TORIC SETUP THEY THOUGHT THEY HAD SELECTED THE CORRECT TORIC LENS AND POWER SETTINGS AND CONTINUED WITH THE TREATMENT. AFTER TREATMENT THE MARKS WERE AT AXIS OF 0 AND 180 RATHER THAN 102 AND 282.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321908 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, LLC 70-00005-001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other