BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 4151974 · Received October 6, 2014

    Report

    Report Number
    3008772169-2014-00140
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ALCON LENSX INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING LASER ASSISTED CATARACT SURGERY, THE CAPSULOTOMY WAS NOT COMPLETED BY THE LASER. AN ANTERIOR CAPSULE TEAR OCCURED WHILE COMPLETING THE CAPSULOTOMY BY CONVENTIONAL METHOD. A SULCUS PLACED INTRAOCULAR LENS WAS IMPLANTED. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624934 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other