BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 8607876 · Received May 14, 2019

    Report

    Report Number
    2028159-2019-00868
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 14, 2019
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. ALCON LENSX (B)(4) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. (B)(4). THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SITE CLINICAL APPLICATION SPECIALIST REPORTED; FOLLOWING THE LASER PORTION OF LASER ASSISTED CATARACT SURGERY, A SUPERIOR TAG WAS NOTICED. THE SURGEON CAREFULLY COMPLETED THE RHEXIS AND DURING PHACO THE ANTERIOR CAPSULE TEAR EXTENDED TO THE POSTERIOR CAPSULE AND AN ANTERIOR VITRECTOMY WAS PERFORMED. ALL LENS FRAGMENTS WERE SUCCESSFULLY REMOVED AND A SULCUS LENS WAS IMPLANTED SUCCESSFULLY. THE OUTCOME IS RESOLVED. THE SURGEON ATTRIBUTES THE TEAR TO THE AREA OF MICRO ADHESION ON THE CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403861 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention