BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 6060704 · Received October 27, 2016

    Report

    Report Number
    3008772169-2016-00709
    Event Type
    Injury
    Date Received
    October 27, 2016
    Report Date
    December 13, 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 Location
    TX, 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 DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO INFORMATION HAS BEEN PROVIDED TO DATE. SULCUS IMPLANT COMPLICATIONS AND VITRECTOMY OCCURRENCES ARE RELATED TO THE OCCURRENCE OF TEARS IN THE POSTERIOR CHAMBER. OTHER CONTRIBUTING FACTORS SUCH AS SURGICAL TECHNIQUE, PATIENT ANATOMY, AND MOVEMENT ALSO CONTRIBUTE TO A POSTERIOR CAPSULE TEAR. 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 HE FEELS HE HAS HAD AN INCREASED NUMBER OF POSTERIOR CAPSULE TEARS WITH ANTERIOR VITRECTOMY AND INTRAOCULAR LENS (IOL) IMPLANTS IN THE SULCUS WITH LASER ASSISTED CATARACT PROCEDURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712795 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R