BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 6142316 · Received December 2, 2016

    Report

    Report Number
    3008772169-2016-00806
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 10, 2016
    Report Date
    February 24, 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
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED IN DEVICE EVALUATED BY MFR?, EVALUATION CODES, AND ADDITIONAL MFR NARRATIVE. 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).

    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 VITREOUS LOSS DURING LASER ASSISTED CATARACT SURGERY OF THE LEFT EYE. NO ISSUES WERE NOTICED DURING LASER TREATMENT; DURING PHACO THE SURGEON NOTICED VITREOUS LOSS, A VITRECTOMY WAS PERFORMED AND A THREE PIECE LENS WAS IMPLANTED. UPON ADDITIONAL FOLLOW UP; THE SURGEON IS NOT SURE AS TO THE EXACT CAUSE OF THE VITREOUS LOSS, THE ANATOMY AND CATARACT WERE FACTORS. THE CATARACT WAS SO DENSE THAT HE COULD NOT SEE BEHIND IT WHILE DOING THE PHACO PORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793347 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention