BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 19718796 · Received July 11, 2024

    Report

    Report Number
    2028159-2024-01005
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 4, 2024
    Report Date
    October 15, 2024
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    OOE
    UDI-DI
    00380659981623
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.11. A MANUFACTURING DEVICE HISTORY RECORD 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. THE COMPANY REPRESENTATIVE WAS UNABLE TO CONFIRM NOR REPLICATE THE REPORTED EVENT. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. A ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    H.3., H.6.: 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 · 0

    A CUSTOMER REPORTED AN ISSUE WITH A CAPSULE TEAR IN A PATIENT'S LEFT EYE DURING CATARACT SURGERY. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS SPECIFIC REPORT ADDRESSES PATIENT'S DIJ WITH THE LEFT EYE ISSUE, AND ADDITIONAL REPORTS FROM OTHER MANUFACTURERS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235810 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER 550 14A0X3 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other