BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 4884226 · Received July 1, 2015

    Report

    Report Number
    3008772169-2015-00611
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    June 8, 2015
    Report Date
    September 9, 2015
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. DURING THE ON-SITE REVIEW, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE SYSTEM AND IT WAS FOUND TO MEET SPECIFICATIONS. AS THERE ARE MULTIPLE FACTORS THAT COULD CONTRIBUTE TO A DESCEMET¿S DETACHMENT, INCLUDING NON-SYSTEM FACTORS, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED A CASE OF DESCEMET DETACHMENT, OBSERVED DURING A LASER ASSISTED CATARACT PROCEDURE. REPORTER INDICATED THE PROCEDURE WAS COMPLETED VIA CONVENTIONAL CATARACT METHOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425241 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other