BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 5028221 · Received August 25, 2015

    Report

    Report Number
    3008772169-2015-00655
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    July 28, 2015
    Report Date
    January 8, 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
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON QUALITY ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THERE IS INSUFFICIENT EVIDENCE TO CONCLUDE THAT A SYSTEM MALFUNCTION CONTRIBUTED OR CAUSED THE REPORTED EVENT. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A LASER ASSISTED CATARACT PROCEDURE, THE PRIMARY INCISION SEEMED SHORT AND MORE ANTERIOR THAN PLANNED. IT SEEMED TO ORIGINATE DEEP INTO THE ANTERIOR CHAMBER. THE SECONDARY INCISION ORIGINATED INTO THE ENDOTHELIUM AND CREATED A MINOR SEPARATION OF DESCEMET'S. THE SURGEON HAD TO CREATE A SECONDARY INCISION IN A NEW LOCATION TO AVOID THE TOTAL SEPARATION OF THE DESCEMET'S AND TO COMPLETE THE PROCEDURE WITHOUT FURTHER HARM TO THE PATIENT. ADDITIONAL INFORMATION PROVIDED STATES THAT THE PROCEDURE PROCEEDED WITHOUT FURTHER INCIDENT. PHACO WAS PERFORMED AND AN INTRAOCULAR IMPLANT WAS SUCCESSFULLY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562037 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R