BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 5094940 · Received September 22, 2015

    Report

    Report Number
    3008772169-2015-00727
    Event Type
    Injury
    Date Received
    September 22, 2015
    Date of Event
    August 10, 2015
    Report Date
    January 11, 2016
    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
    UP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE IS EXPECTED FOR EVALUATION. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. THE ASSOCIATED DEVICE WAS RELEASED BASED ON THE MANUFACTURER'S ACCEPTANCE CRITERIA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS RECEIVED. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AFTER CREATION OF THE FLAP, THERE WERE SECTIONS THAT THE LASER DID NOT CUT. PER THE SURGEON, THIS MADE IT DIFFICULT TO LIFT THE FLAP, SO HE APPLIED FORCE WHEN HE LIFTED IT. SUBSEQUENTLY THE SURGEON NOTED RUPTURES ON THE CORNEAL TISSUE, WHICH HE DESCRIBED AS "ISLANDS" OF STROMA. THE LASIK PROCEDURE WAS COMPLETED. THE PATIENT WAS TREATED WITH INCREASED TOPICAL STEROID DROPS. THE EVENT RESOLVED WITH THE TREATMENT. NO FURTHER INFORMATION IS EXPECTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626851 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other| R