BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR

    MDR report key: 12544803 · Received September 28, 2021

    Report

    Report Number
    2020664-2021-07581
    Event Type
    Injury
    Date Received
    September 28, 2021
    Report Date
    September 28, 2021
    Product Code
    LZS
    UDI-DI
    00(01)(21)3733
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (DATE OF BIRTH), UNKNOWN/NOT PROVIDED. DATE OF EVENT: UNKNOWN/NOT PROVIDED. AN APPLICATION SUPPORT MANAGER (ASM) DISCUSSED WITH CUSTOMER REGARDING THE CALIBRATION FACTOR AND THE ACCEPTABLE CHANGES THE DOWNSIDE OF NOT BEING ABLE TO VERIFY REGISTRATION OF THE IRIS REGISTRATION (IR) AND EXPLAINED IT WILL NOT INCORPORATE PUPIL CENTROID SHIFT AND CYCLOROTATION OF THE EYE. IT WAS NOT COMMON THAT THEY COULD NOT GET IR TO VERIFY. ALL QUESTIONS CUSTOMER HAD WERE ANSWERED BY ASM. A REVIEW OF THE RECORDS RELATED TO THIS EQUIPMENT THAT INCLUDED LABELING, MANUAL, AND RISK DOCUMENTATION REVIEWS FOR THIS EQUIPMENT WAS PERFORMED. EQUIPMENT LABELING PROVIDES POSSIBLE COMPLICATIONS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT WAS TREATED (B)(6) 2020 WITH IDESIGN AND PHOTOREFRACTIVE KERATECTOMY (PRK) THAT WAS OVERCORRECTED. ORIGINAL RX WAS -1.25 +0.75 AND THE PATIENT ENDED UP BEING +.25 +.75. PATIENT WAS RETREATED IN (B)(6) 2021. NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) REPORTED. PATIENT IS DOING WELL. THIS REPORT IS THE EXCIMER LASER. A SEPARATE REPORT WILL BE FILED FOR THE IDESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441962 STAR S4 IR EXCIMER LASER SYSTEM LZS 0030-1479 00(01)(21)3733

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IDESIGN SN (B)(4)