BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR

    MDR report key: 16710854 · Received April 11, 2023

    Report

    Report Number
    3012236936-2023-00886
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    December 22, 2022
    Report Date
    April 10, 2023
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    UDI-DI
    00(01)(21)3669
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: AN APPLICATION SUPPORT MANAGER (ASM) VISITED SITE AND PROVIDED SURGERY SUPPORT. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD SURGERY ON (B)(6) 2022 AND WAS OVERCORRECTED IN THE LEFT EYE. IDESIGN MANIFEST REFRACTION (MR) -9.12 +2.90 X 100, MR. -8.25 +2.75 97 BEST CORRECTED VISUAL ACUITY (BCVA) 20/20. AN ENHANCEMENT WAS PERFORMED ON (B)(6) 2022. IDESIGN MR -.10 +1.14 X79, MR +1.25 SPH. PHYSICIAN ADJ +.50. PATIENT ENDED UP WITH 20/25 UNCORRECTED VISUAL ACUITY (UCVA). NO REFRACTION HAS BEEN DONE AND PATIENT IS NOT DUE TO RETURN FOR ANOTHER 6 MONTHS. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE EXCIMER LASER. A SEPARATE REPORT WILL BE FILED FOR THE IDESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425042 STAR S4 IR EXCIMER LASER SYSTEM LZS AMO MANUFACTURING USA, LLC 0030-1479 00(01)(21)3669

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention IDESIGN SN (B)(4).