BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 4476274 · Received May 15, 2014

    Report

    Report Number
    3008772169-2014-00055
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 19, 2014
    Manufacturer
    ALCON - LENSX LASERS INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED PATIENT WITH SUB-INCISIONAL CAPSULE TEAR OF THE RIGHT EYE AFTER FEMTOSECOND TREATMENT. ADDITIONAL INFORMATION FROM REPORTER INDICATED THERE WAS EXTREME MOVEMENT DURING THE PROCEDURE AND PATIENT HAD AN INCOMPLETE CAPSULOTOMY. THE REPORTER INDICATED A VITRECTOMY WAS PERFORMED SUCCESSFULLY IN ORDER TO TREAT THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293465 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention