BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 4906435 · Received July 10, 2015

    Report

    Report Number
    3008772169-2015-00617
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    June 16, 2015
    Report Date
    December 4, 2015
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE IS EXPECTED FOR EVALUATION. ALTHOUGH IT WAS REQUESTED, NO FURTHER INFORMATION WAS RECEIVED FROM THE REPORTER. AFTER REVIEW OF REPORTED EVENT, THERE IS NO EVIDENCE INDICATING THAT THE IRIS PROLAPSE WAS CAUSED BY THE PERFORMANCE OF THE SYSTEM. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE EVENT COULD NOT BE CONFIRMED. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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 DURING LASER-ASSISTED CATARACT SURGERY, THE CAPSULOTOMY WAS NOT COMPLETED. THE SURGEON PROCEEDED TO MANUALLY COMPLETE THE CAPSULOTOMY. SHORTLY AFTER, UPON OPENING THE INCISION, THE SURGEON NOTICED THAT THE IRIS PROLAPSED AND WENT THROUGH THE WOUND. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE, AFTER REPOSITIONING THE IRIS. ACCORDING TO THE SURGEON, THE PATIENT WAS TAKING A MEDICATION THAT MAY HAVE CAUSED A "FLOPPY IRIS." ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE POSTOPERATIVE STATUS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450466 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R