BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 14157596 · Received April 20, 2022

    Report

    Report Number
    2028159-2022-00537
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 25, 2022
    Report Date
    September 1, 2022
    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
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. IRVINE 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. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT/BATCH/SERIAL NUMBER WAS PERFORMED. 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) OPENED FEBRUARY 28, 2022. THE SYSTEM FOUND TO MEET ALL COSMETIC AND PERFORMANCE STANDARDS, PER THE SERVICE TEST PROCEDURE (STP). THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THE PATIENT HAD RUPTURE OF THE POSTERIOR CAPSULE DURING REMOVAL OF THE CORTEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2718063 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other LENSX LASER SYSTEM