BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YC-1800

    MDR report key: 10209547 · Received June 29, 2020

    Report

    Report Number
    0002936921-2020-00002
    Event Type
    Injury
    Date Received
    June 29, 2020
    Date of Event
    May 29, 2020
    Report Date
    June 29, 2020
    Manufacturer
    NIDEK INC.
    Product Code
    LXS
    PMA / PMN Number
    K893987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NIDEK INC. SERVICE MANAGER RECEIVED AN EMAIL FROM A DOCTOR ON (B)(6) 2020 TO REPORT AN ADVERSE EVENT WITH THE NIDEK YAG LASER. THE DOCTOR HAD A PATIENT ON THE WEEK OF (B)(6) 2020 WHERE THE YAG LASER WAS USED FOR CAPSULOTOMY. ACCORDING TO THE DOCTOR, THE FOCUS WAS CORRECT, HOWEVER THE LASER FIRED MORE ANTERIORLY THAN THE FOCUSING LASER RESULTING IN IOL PITTING. NIDEK INC. SERVICE MANAGER CONTACTED THE CUSTOMER REGARDING ADDITIONAL PATIENT INFORMATION AND THE REPORTED PROBLEM ON (B)(6) 2020, (B)(6) 2020, (B)(6) /2020, HOWEVER; NO RESPONSE FROM THE DOCTOR WAS PROVIDED. SINCE NIDEK INC IS UNABLE TO OBTAIN THE DEVICE FOR ANALYSIS, FURTHER INVESTIGATION CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    NIDEK INC. SERVICE MANAGER RECEIVED AN EMAIL FROM A DOCTOR ON (B)(6) 2020 TO REPORT AN ADVERSE EVENT WITH THE NIDEK YAG LASER. THE DOCTOR HAD A PATIENT ON THE WEEK OF (B)(6) 2020 WHERE THE YAG LASER WAS USED FOR CAPSULOTOMY. ACCORDING TO THE DOCTOR, THE FOCUS WAS CORRECT, HOWEVER THE LASER FIRED MORE ANTERIORLY THAN THE FOCUSING LASER RESULTING IN IOL PITTING. NIDEK INC. SERVICE MANAGER CONTACTED THE CUSTOMER REGARDING ADDITIONAL PATIENT INFORMATION AND THE REPORTED PROBLEM ON (B)(6) 2020, (B)(6) 2020, (B)(6) 2020, HOWEVER; NO RESPONSE FROM THE DOCTOR WAS PROVIDED. SINCE NIDEK INC IS UNABLE TO OBTAIN THE DEVICE FOR ANALYSIS, FURTHER INVESTIGATION CANNOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671651 YC-1800 YAG LASER LXS NIDEK INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O