BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 15750427 · Received November 8, 2022

    Report

    Report Number
    2028159-2022-01579
    Event Type
    Injury
    Date Received
    November 8, 2022
    Date of Event
    October 18, 2022
    Report Date
    January 19, 2023
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    UDI-DI
    00380659981623
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. (B)(4) TECHNOLOGY CENTER SITE #(B)(4)). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. SERVICE HISTORY WAS REVIEWED FOR THE SYSTEM. NO SERVICE RECORD RELEVANT TO THE COMPLAINT REPORTED EVENT WAS FOUND. HOWEVER, THE SYSTEM WAS LAST SERVICED, PRIOR TO THE REPORTED EVENT PER SERVICE RECORD (SR). THE SYSTEM FOUND TO MEET ALL COSMETIC AND PERFORMANCE STANDARDS AT THAT TIME. BASED ON THE INFORMATION AVAILABLE, THE CUSTOMER REPORTED EVENT CANNOT BE CONFIRMED. POSTERIOR CAPSULE TEAR IS AN ISSUE, THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. HOWEVER, A REVIEW OF THE COMPLAINT TRENDS SHOWS, THAT THE FREQUENCY REPORTED IS WITHIN KNOWN LEVELS FOR THIS EVENT. A ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED A PATIENT WITH LARGE HOLE IN THE POSTERIOR CAPSULE OF RIGHT EYE POST LASIK SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251594 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other