BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2960329 · Received February 8, 2013

    Report

    Report Number
    3008772169-2013-00008
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ALCON - LENSX LASERS, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: 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

    THE SURGEON REPORTED THAT THE ENERGY EFFICIENCY FLUCTUATED STRONGLY CAUSING "TISSUE BRIDGES." THE REPORTER INFORMED THAT AN INCOMPLETE CAPSULORHEXIS WITH ADHESION OCCURRED DURING REFRACTIVE LENS EXCHANGE. THERE WAS A TEAR OF THE CAPSULE OF THE RIGHT EYE (OD), AND VITREOUS FLUID WAS LOST DURING THE CORTEX REMOVAL. ANTERIOR VITRECTOMY WAS PERFORMED. PER THE SURGEON, THE SYMPTOMS WERE RESOLVED. ADDITIONAL CLARIFICATION WAS RECEIVED INFORMING THAT DURING THE ASPIRATION OF THE LENS RIND (CORTEX) WITH THE BIMANUAL HANDPIECE, THE TEAR OCCURRED WHEN THE METAL TIP TOUCHED THE CAPSULAR BAG, AT THE 4 O'CLOCK POSITION. THEN, THE TEAR WENT FURTHER TO THE ANTERIOR PART OF THE CAPSULAR BAG. FOUR DAYS AFTER THE INITIAL SURGERY, THE INTRAOCULAR LENS WAS EXCHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53118 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention HEALON