BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 6429910 · Received March 23, 2017

    Report

    Report Number
    3008772169-2017-00137
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    August 17, 2016
    Report Date
    June 23, 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
    RS
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THERE WERE NO TECHNICAL SERVICES REQUESTED OR PERFORMED RELATED TO THE REPORTED EVENT. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED DESCEMET'S MEMBRANE HOLE WAS OBSERVED AT ONE DAY POST LASER ASSISTED CATARACT SURGERY OF THE RIGHT EYE. REPORTER INDICATED CORNEAL EDEMA WAS PRESENT AND THE ISSUE MAY BE RELATED TO THE EDEMA. THE EXACT CAUSE OF ITS OCCURRENCE DOCTORS DO NOT KNOW. PATIENT WAS PLACED ON AN UNDISCLOSED PHARMACEUTICAL TREATMENT. UPON FOLLOW UP, THE REPORTER INDICATED THE REPORTED ISSUE HAS RESOLVED. DOCTOR DOES NOT WISH TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209166 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention