BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 6113199 · Received November 18, 2016

    Report

    Report Number
    3008772169-2016-00790
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    November 1, 2016
    Report Date
    February 16, 2017
    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 Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED IN DEVICE EVALUATED BY MFR?, EVALUATION CODES, AND ADDITIONAL MFR NARRATIVE.. THE INVESTIGATION DID NOT IDENTIFY ANY SYSTEM ISSUES THAT WOULD INDICATE THAT THE LASER CONTRIBUTED TO THE REPORTED EVENT. 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 DOCTOR REPORTED MICROADHESIONS ON THE ANTERIOR CAPSULOTOMY IN A PATIENT'S RIGHT EYE DURING LASER ASSISTED CATARACT SURGERY. THE DOCTOR COMPLETED THE CAPSULOTOMY BY CIRCUMFERENTIALLY DETACHING ADHESIONS. DURING HYDRODISSECTION, THAT ANTERIOR CAPSULE EXTENDED AT THE POINT OF THE ADHESION. THE DOCTOR COMPLETED THE PROCEDURE BY PLACING A POSTERIOR CAPSULE INTRAOCULAR LENS (IOL) IN THE BAG WITHOUT ANY FURTHER INCIDENTS. THE EXTENSION WAS NOTED TO NOT HAVE CONTINUED TO THE POSTERIOR CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763150 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other