BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 8564581 · Received April 30, 2019

    Report

    Report Number
    2028159-2019-00786
    Event Type
    Injury
    Date Received
    April 30, 2019
    Date of Event
    October 6, 2018
    Report Date
    April 30, 2019
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REVIEW OF THE REPORTED EVENT AS WELL AS RELATED LITERATURE, THERE IS NO EVIDENCE INDICATING THAT THE INTEGRITY OF THE POSTERIOR CAPSULE WAS COMPROMISED BY THE PERFORMANCE OF THE SYSTEM. THE MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. 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 CUSTOMER REPORTED AN INCOMPLETE CAPSULORHEXIS OCCURRED DURING LASER ASSISTED CATARACT SURGERY (BETWEEN 0 TO 90 DEGREES). THE DOCTOR TRIED TO MANUALLY HANDLE THE CAPSULORHEXIS BUT THE CAPSULAR BAD RUPTURED. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359257 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other