BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 6078667 · Received November 4, 2016

    Report

    Report Number
    3008772169-2016-00753
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    October 10, 2016
    Report Date
    December 19, 2016
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED AN INCOMPLETE CAPSULORHEXIS, SIDEPORT AND NUCLEUS FRAGMENTATION DURING LASER ASSISTED CATARACT SURGERY. A NICHE WAS CREATED IN THE POSTERIOR CAPSULE REQUIRING AN ANTERIOR VITRECTOMY FOLLOWED BY CONVERSION TO EXTRACAPSULAR CATARACT SURGERY. AN IRIS CLAW INTRAOCULAR LENS WAS IMPLANTED AND SIX SUTURES WERE REQUIRED TO CLOSE THE INCISION. IT WAS ALSO REPORTED THAT PRIOR TO OPENING THE INCISIONS A FILM IN THE ANTERIOR CHAMBER WAS NOTED AND INDICATED BY THE SURGEON THAT THIS COULD HAVE BLOCKED THE LASER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731413 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R