BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSAR LASER SYSTEM -FS 3D

    MDR report key: 5021084 · Received August 12, 2015

    Report

    Report Number
    3009026057-2015-00025
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 16, 2015
    Report Date
    August 11, 2015
    Manufacturer
    LENSAR INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    1

    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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2015 A DOCTOR REQUESTED A (B)(6) TO REVIEW A FILE FROM (B)(6) 2015. THEY STATED THAT THE LASER PORTION WENT WELL AND NO ISSUES OTHER THAN TAG DEFENDER MESSAGE. THE LASER SURGERY COMPLETED 100%. AFTER PHACO PORTION OF SURGERY AND BEFORE I AND A, EVIDENCE OF VITREOUS WAS PRESENT. AN ANTERIOR VITRECTOMY WAS PERFORMED AND FOLLOWED BY PLACEMENT OF IOL IN THE ANTERIOR CHAMBER. THE DOCTOR DID NOT SEE ANY RADIAL OR POSTERIOR TEARS IN THE CAPSULE AS THE REMOVAL OF THE CAPSULOTOMY BUTTON WAS COMPLETE AND SUCCESSFUL. THE DOCTOR STATED THAT HE DID NOTICE THE ZONULES LOOKED WEAK WHICH MAY HAVE CONTRIBUTED TO THE DIFFICULTY OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532040 LENSAR LASER SYSTEM -FS 3D LENSAR LASER SYSTEM -FS 3D OOE LENSAR INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| O