BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 5059657 · Received September 7, 2015

    Report

    Report Number
    3008772169-2015-00691
    Event Type
    Injury
    Date Received
    September 7, 2015
    Date of Event
    August 13, 2015
    Report Date
    January 12, 2016
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THERE WERE NO SYSTEM SETTINGS, OPTICAL COHERENCE TOMOGRAPHY (OCT) IMAGES OR VIDEO IMAGES PROVIDED FOR REVIEW TO DETERMINE IF THERE WERE ANY OBSTRUCTIONS OR TREATMENT ABNORMALITIES THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. THE LASER SYSTEM ALLOWS THE USER TO SELECT THE PLACEMENTS OF THE PROGRAMMED INCISIONS. THE SYSTEM THEN FIRES FEMTOSECOND LASER PULSES TO CREATE PERFORATED INCISIONS. THE INCISIONS ARE NOT OPENED IMMEDIATELY FOLLOWING THE LASER TREATMENT AND ARE REQUIRED TO BE OPENED BY A SURGEON IN THE OPERATING ROOM BEFORE THE REMAINING STEPS OF THE CATARACT PROCEDURE CAN BE PERFORMED. THE INCISIONS CAN UNDERGO SIGNIFICANT MANIPULATION WHEN THEY ARE OPENED AND AS THE REMAINING STEPS OF THE CATARACT PROCEDURE ARE COMPLETED FOLLOWING THE LASER TREATMENT. SUTURES ARE USED TO ENSURE CLOSURE OF AN OPENED INCISION THAT MAY NO LONGER BE SELF-SEALING AND ARE USED IN BOTH, LASER-ASSISTED AND MANUAL CATARACT PROCEDURES. THE NEED FOR A SUTURE CAN BE A RESULT OF THE SURGICAL TECHNIQUE AND PATIENT ANATOMY IN ADDITION TO A SYSTEM RELATED ISSUE. THE LICENSED/TRAINED OPERATOR SHOULD BE COMPETENT IN MITIGATING THE RISK OF ANY DIRECT PATIENT HARM SIMILAR TO WHAT WOULD BE REQUIRED IN A MANUAL CATARACT PROCEDURE. THERE WERE ALSO NO REPORTED SYSTEM MESSAGES OR SYSTEM ISSUES THAT WOULD CLEARLY INDICATE THAT THE LASER SYSTEM CAUSED OR CONTRIBUTED TO THE EVENT. THE SYSTEM MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY.

    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).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED THAT SUTURES WERE REQUIRED TO SEW THE PARACENTESIS AS IT WAS NOT SEALED PROPERLY. IT WAS THE PARACENTESIS LEFT TO THE MAIN INCISION. THE SURGEON WAS SATISFIED WITH THE MAIN INCISION AND ALSO WITH THE OTHER INCISIONS. THIS IS ONE OF TWO REPORTS BEING FILED FOR THIS FACILITY. THIS REPORT IS FOR THE SECOND PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591036 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention