BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 3122074 · Received May 16, 2013

    Report

    Report Number
    3008772169-2013-00035
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE LASER; THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. BASED ON AVAILABLE INFORMATION, THE PATIENT'S MOVEMENT WAS LIKELY A CONTRIBUTING CAUSE TO THE REPORTED EVENT.(B)(4).

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE ON BEHALF OF THE CUSTOMER REPORTED A RHEXIS TEAR ON A PATIENT THAT MOVED DURING THE FIRST 7 SECONDS OF A PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217358 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other