BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 8037276 · Received November 5, 2018

    Report

    Report Number
    2028159-2018-02307
    Event Type
    Injury
    Date Received
    November 5, 2018
    Date of Event
    October 8, 2018
    Report Date
    January 16, 2019
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. ALCON LENSX (SITE #3008772169) 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 · 1

    (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A SMALL TAG IN THE CAPSULARHEXIS DURING LASER ASSISTED CATARACT SURGERY. DURING HYDRODISSECTION, A RADIAL TEAR DEVELOPED. THE TEAR WENT AROUND TO THE POSTERIOR CAPSULE. THE CATARACT WAS REMOVED AND VITREOUS PRESENTED. AN ANTERIOR VITRECTOMY WAS PERFORMED AND AN INTRAOCULAR LENS WAS PLACED IN THE SULCUS. THE PATIENT WAS SEEN THE NEXT DAY AND WAS DOING WELL WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877276 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention