BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 12181905 · Received July 16, 2021

    Report

    Report Number
    2028159-2021-00754
    Event Type
    Injury
    Date Received
    July 16, 2021
    Date of Event
    June 21, 2021
    Report Date
    August 16, 2021
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    UDI-DI
    00380659981623
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION PROVIDED. A SUPPLEMENTAL MEDICAL DEVICE REPORT (SMDR) # 02 IS BEING FILED TO ALERT THAT INFORMATION PROVIDED IN G.1 ON SMDR # 01 WAS INCORRECT . CORRECT G.1 INFORMATION WAS PROVIDED ON THE MEDICAL DEVICE REPORT (MDR). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED. THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. 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. ALCON LENSX (SITE # (B)(4)) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. IRVINE TECHNOLOGY CENTER (SITE # (B)(4)). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A CASE OF GAS BREAKTHROUGH, IN THE EPITHELIUM OF PATIENT'S LEFT EYE IN THE AREA OF TWELVE-THIRTEEN HOUR, DURING FEMTOSECOND LASER FLAP CREATION ON A PATIENT¿S LEFT EYE. PHYSICIAN DID NOT ATTEMPT TO LIFT THE FLAP, AND DISSECTION WAS STOPPED BEFORE ENTERING THE PROJECTION AREA OF THE PUPIL. POST-OPERATIVE ONE DAY, THE PATIENT STATED BEING CONCERNED ABOUT THE SENSATION OF A FOREIGN BODY AND LACRIMATION. THE EPITHELIUM IN THE AREA OF THE BREAKTHROUGH WAS REPORTED TO BE UNEVEN. REPORTER INFORMED THAT GROSS EPITHELIAL DEFECTS, EPITHELIAL OPACITIES, DIDN'T ALLOW TO PERFORM A SECOND PROCEDURE. AFTER THE OPERATION, SOFT CONTACT LENS WAS APPLIED. IT WAS REPORTED THAT, WHEN MEASURED WITH OPTICAL COHERENCE TOMOGRAPHY, THE THICKNESS OF THE FLAP NEAR THE GAS BREAKTHROUGH WAS 80-90 MICRONS, AND THE OPERATION WAS POSTPONED FOR ONE WEEK. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES PATIENT MYAD'S LEFT EYE AND ANOTHER MANUFACTURER REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081480 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other| R