BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 11752210 · Received April 30, 2021

    Report

    Report Number
    1644019-2021-00295
    Event Type
    Injury
    Date Received
    April 30, 2021
    Report Date
    June 14, 2021
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    OOE
    UDI-DI
    00380659982255
    PMA / PMN Number
    K123120
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER, INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    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).

    Description of Event or Problem · 1

    A NURSE REPORTED DURING POST PHACOEMULSIFICATION OF THE EXTREMELY HARD NUCLEUS, THE PUPIL WAS CLOSED AND NON-RESPONSIVE. RUPTURE OF CAPSULE OCCURRED DUE TO CORTICAL ASPIRATION WITH MIOSIS. VITRECTOMY PERFORMED AND SURGERY WAS RESCHEDULED. PATIENT'S SYMPTOMS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652715 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON RESEARCH, LLC - HOUSTON 550 2389326H 00380659982255

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention