BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 4121313 · Received September 22, 2014

    Report

    Report Number
    3008772169-2014-00131
    Event Type
    Injury
    Date Received
    September 22, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    ALCON - LENSX LASERS INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 THAT HE HAD A PATIENT THAT HAD AN ANTERIOR CAPSULE TEAR, AFTER LASER ASSISTED CATARACT SURGERY. THE SURGEON SAW NO POSTERIOR EXTENSION, BUT A SUTURE WAS PLACED AS A PRECAUTION. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587545 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention