BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 3820787 · Received May 8, 2014

    Report

    Report Number
    3008772169-2014-00045
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ALCON - LENSX INC.
    Product Code
    OOE
    PMA / PMN Number
    K10626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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).

    Description of Event or Problem · 1

    A SURGEON REPORTED A CASE OF AN ANTERIOR CAPSULE RADIAL TEAR THAT OCCURRED AT THE "7-9 O'CLOCK" POSITION IN A PATIENT'S RIGHT EYE DURING LASER ASSISTED CATARACT PROCEDURE. REPORTER INDICATED ONE MICRO-ADHESION WAS NOTED FOLLOWING AT THE "8 O'CLOCK" POSITION, THE INTRAOCULAR LENS WAS SUCCESSFULLY IMPLANTED IN CAPSULAR BAG. THE SURGEON, ADDITIONALLY, RELAYED THE PATIENT OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279155 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX INC. 550 LA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other UNK.