BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 7096886 · Received December 7, 2017

    Report

    Report Number
    3008772169-2017-00565
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 14, 2017
    Report Date
    June 14, 2018
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AS WITH ANY SURGICAL PROCEDURE, RISK IS INVOLVED. POSSIBLE COMPLICATIONS RESULTING FROM LAMELLAR FLAP RESECTION INCLUDE (BUT ARE NOT LIMITED TO): CORNEAL EDEMA, CORNEAL PAIN, EPITHELIAL IN-GROWTH, EPITHELIAL DEFECT, INFECTION, FLAP DECENTRATION, INCOMPLETE FLAP CREATION, FLAP TEARING OR INCOMPLETE LIFT-OFF, AND FREE CAP. A COMPANY REPRESENTATIVE (CR) VISITED THE SITE TO EVALUATE THE SYSTEM. PER THE SERVICE REPORT, THE CR ADJUSTED THE LASER BEAM AND SPOT SIZE MEASUREMENT. IT WAS NOTED THAT THE TIMING AND AMP POCKELS CELL TOOK A LONG TIME TO BECOME STABLE. THE SYSTEM MET SPECIFICATIONS PRIOR TO THE DEPARTURE OF THE CR. THE CR REPLACED THE AMP POCKELS CELL TO ADDRESS THE POCKELS CELL STABILITY TIME. THE WORK PERFORMED ON THE SYSTEM WAS DONE AS A PREVENTATIVE MEASURE. THE SYSTEM MET SPECS PRIOR TO THE CR¿S DEPARTURE. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED. THE SYSTEM WAS EXAMINED. THE COMPANY REPRESENTATIVE DID NOT INDICATE FINDING ANY ISSUES THAT WOULD BE ASSOCIATED WITH THE REPORTED EVENT. HOWEVER, ADJUSTMENTS WERE MADE TO OPTIMIZE THE SYSTEM. THERE WERE NO REPORTED ISSUES FOLLOWING THE ADJUSTMENT. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. A REVIEW OF THE CUSTOMER¿S COMPLAINT HISTORY DID NOT SHOW ANY PREVIOUS COMPLAINTS OF THIS KIND AGAINST THE SYSTEM. THE ROOT CAUSE OF THE REPORTED ¿DIFFICULTY TO LIFT FLAP/INCOMPLETE FLAP¿ CAN BE ATTRIBUTED TO A USE ERROR. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

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

    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

    NEW INFORMATION WAS RECEIVED FROM A CLINICAL APPLICATIONS SPECIALIST INFORMING THAT THIS WAS AN OPERATOR ERROR. THE TWO PHYSICIANS ARE CERTIFIED ON THE LASER ON HOW TO CREATE FLAPS. HOWEVER, THEY PERFORM LASIK SURGERIES VERY IRREGULARLY AND DO NOT HAVE THE ROUTINE DOWN. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT IS UNSURE WHETHER THIS WAS AN OPERATOR ERROR WHICH HAD NOTHING TO DO WITH THE LASER. PHYSICIANS HAD TROUBLE LISTENING TO COMPANY REPRESENTATIVE INSTRUCTIONS. COMPANY REPRESENTATIVE WILL CONTINUE TO OFFER SUPPORT REGULARLY.

    Description of Event or Problem · 1

    A NURSE REPORTED AN INCOMPLETE FLAP ON A PATIENT'S RIGHT EYE DURING LASER ASSISTED FLAP CREATION PROCEDURE. DOCKING WAS SLIGHTLY SHIFTED AND FLAP WAS MANUALLY RE-CENTERED ON THE MONITOR. BED SECTION LOOKED NORMAL ON THE MONITOR. IT WAS VISIBLE ON THE MONITOR THAT THE EDGE SECTION AT 6 O'CLOCK WAS NOT QUITE COMPLETE. WHILE THE FLAP WAS LIFTED, TISSUE BRIDGES WERE NOTED. AN INCREASE IN OPAQUE BUBBLE LAYER WAS VISIBLE AT THE INTERFACE. FLAP WAS STILL LIFTED AND REGULAR TREATMENT WAS COMPLETED WITH THE EXCIMER LASER. THE NURSE SUSPECTS AN APPLICATION ERROR DUE TO POOR DOCKING BY THE SURGEON. UPON FOLLOW UP, NO PATIENT HARM WAS REPORTED. EVERYTHING WENT WILL AND PROCEDURE WAS PERFORMED TO CORRECT PATIENT'S ASTIGMATISM. UPON ADDITIONAL FOLLOW UP, THE LEADING SURGERY NURSE SAID THAT IN HER OPINION THE EVENT WAS DUE TO INSUFFICIENT DOCKING. UNFORTUNATELY, THE COMPANY REPRESENTATIVE CONTACTED IS STILL LEARNING/TRAINING ON THIS SYSTEM AND COULD NOT REALLY SAY WHAT THE UNDERLYING CAUSE FOR THE TISSUE BRIDGE WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877437 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other