BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 21879894 · Received April 22, 2025

    Report

    Report Number
    2028159-2025-00513
    Event Type
    Injury
    Date Received
    April 22, 2025
    Date of Event
    March 28, 2025
    Report Date
    June 9, 2025
    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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.3., H.6., AND H.11. 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) OPENED. THE SYSTEM FOUND TO MEET ALL COSMETIC AND PERFORMANCE STANDARDS. 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. ALCON LENSX (SITE #3008772169) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. IRVINE TECHNOLOGY CENTER SITE #2028159). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS:(B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT AN ANTERIOR CAPSULAR TEAR IN THE UNKNOWN EYE DURING CATARACT SURGERY. SURGEON REPORTS GOOD VISUALIZATION OF THE CAPSULOTOMY AND DOES NOTE ANY TAGS PRESENT ON THESE CASES, NOTICES THE TEAR ONCE THE CATARACT HAS BEEN REMOVED. THE TEARS HAVE NOT EXTENDED TO THE POSTERIOR CAPSULE AND HE HAS BEEN ABLE TO PLACE ALL INTRAOCULAR LENS IN THE BAG. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE UNKNOWN PATIENT INITIAL'S, IN THE UNKNOWN EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352468 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other