BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 8105563 · Received November 27, 2018

    Report

    Report Number
    2028159-2018-02457
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    November 8, 2018
    Report Date
    February 7, 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 · 0

    THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. ALCON LENSX (SITE #(B)(4)) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. IRVINE TECHNOLOGY CENTER (SITE #(B)(4)). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED DURING A LASER ASSISTED CATARACT SURGERY, BEFORE REMOVING THE CORTICAL MATERIAL, AN ANTERIOR CAPSULE TEAR WAS NOTED. THE TEAR WAS NINETY DEGREES AWAY FROM THE CHOPPING. THE PHYSICIAN IS UNSURE WHAT CAUSED THE TEAR OR IF IT WAS LASER RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948287 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other