BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 10839885 · Received November 13, 2020

    Report

    Report Number
    2028159-2020-00975
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    October 30, 2020
    Report Date
    February 4, 2021
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER REVIEW OF REPORTED EVENT, THERE IS NO EVIDENCE INDICATING THAT THE INTEGRITY OF THE ANTERIOR CAPSULE WAS COMPROMISED BY THE PERFORMANCE OF THE SYSTEM. THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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)(6)). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED, DURING LASER ASSISTED CATARACT SURGERY, AN ANTERIOR CAPSULE TEAR OCCURRED. THE IMPLANTED INTRAOCULAR LENS (IOL) WAS REMOVED BECAUSE THE CAPSULAR BAG WAS UNSTABLE. ANOTHER IOL WAS IMPLANTED IN THE SULCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305630 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention