BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 25065521 · Received May 4, 2026

    Report

    Report Number
    2028159-2026-00619
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 4, 2026
    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
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 SHE OBSERVED A BRIEF PUFF AT THE TIME OF CAPSULOTOMY VISUALIZATION OF THE ANTERIOR CAPSULE WAS SEVERELY LIMITED DUE TO THE DENSITY OF THE MATURE CATARACT AND TRYPAN BLUE WAS NOT APPLIED, ONCE THE CAPSULOTOMY WAS COMPLETED A SMALL ANTERIOR CAPSULAR TEAR WAS SUBSEQUENTLY IDENTIFIED BENEATH THE PRIMARY INCISION IN LEFT EYE OF THE PATIENT DURING REFRACTIVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413256 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other