BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 4994669 · Received August 12, 2015

    Report

    Report Number
    3008772169-2015-00642
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 13, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DESCEMET¿S DETACHMENT WAS OBSERVED AFTER SYSTEM MESSAGE (SM) WAS DISPLAYED BY THE SYSTEM. ALTHOUGH THE SM WAS DISPLAYED, IT WAS DETERMINED THAT THIS MESSAGE WAS NOT RELATED TO THE DETACHMENT. HOWEVER, AS NO SERVICES HAVE BEEN PERFORMED, THE CAUSE OF THE SM CANNOT BE DETERMINED. FURTHER, AS THERE ARE MULTIPLE FACTORS THAT COULD CONTRIBUTE TO A DESCEMET¿S DETACHMENT, INCLUDING NON-SYSTEM FACTORS, BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A CASE OF DECEMETS DETACHMENT, DURING LASER ASSISTED CATARACT SURGERY. THE REPORTER INDICATED A LASER SYSTEM MESSAGE DISPLAYED REQUIRING THE LASER TO BE RESET, AT WHICH TIME THE DETACHMENT OCCURED. THE LASER SYSTEM WAS RESET AND THE PROCEDURE WAS REPORTED AS COMPLETED. 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
    528932 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other