BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 6139627 · Received December 1, 2016

    Report

    Report Number
    3008772169-2016-00802
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 7, 2016
    Report Date
    March 30, 2017
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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).

    Additional Manufacturer Narrative · 1

    BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A POSTERIOR CAPSULAR TEAR FOLLOWING LASER ASSISTED CATARACT SURGERY. AFTER LASER TREATMENT WAS COMPLETE, THE SURGEON BEGAN TO REMOVE THE OLD LENS, THERE WAS A POSTERIOR TEAR WHICH REQUIRED A VITRECTOMY. THE SURGEON IS UNSURE IF THE LASER CONTRIBUTED OR IF THERE WERE UNDERLYING ISSUES CAUSING THIS TO OCCUR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788851 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention