BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 4926547 · Received July 20, 2015

    Report

    Report Number
    3008772169-2015-00630
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    July 6, 2015
    Report Date
    September 2, 2015
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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

    A COMPANY CLINICAL SUPPORT REPRESENTATIVE REVIEWED THE CASE, AND FOUND NOTHING CRITICAL. REVIEW OF SELECTED PARAMETERS DID NOT SHOW REASONS TO CONFIRM THE REPORTED ISSUE. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THE REPORTER. WITH NO ADDITIONAL RELATED INFORMATION, THE CUSTOMERS REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. 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

    A DOCTOR REPORTED A DESCEMET'S DETACHMENT IN A PATIENT'S RIGHT EYE IN THE SECONDARY INCISION DURING A LASER ASSISTED CATARACT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468586 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other