BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR

    MDR report key: 21885734 · Received April 22, 2025

    Report

    Report Number
    3012236936-2025-000113
    Event Type
    Injury
    Date Received
    April 22, 2025
    Report Date
    April 22, 2025
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    UDI-DI
    05050474573413
    PMA / PMN Number
    P910062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: AGE: THE AVERAGE AGE OF PATIENTS UNDER-GOING THE PROCEDURE WAS 53 YEARS SECTION A3: GENDER: 18 WERE FEMALE AND 17 MALE. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS NOVEMBER 7, 2022. THE STUDY WAS CONDUCTED FOR SURGERIES PERFORMED BETWEEN (B)(6) 2014. . DEVICE EVALUATION PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED, AND THE REPORTED EVENT CANNOT BE CONFIRMED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED.. CITATION: DARIAN-SMITH, E., GOUVEA, L., GENDLER, S., ALSHAKER, S., DIN, N., WEILL, Y., SKOURAS, N., RABINOVITCH, T., SINGAL, N., CHAN, C. C., & ROOTMAN, D. S. (2024). KAMRA PRESBYOPIC INLAY REFRACTIVE OUTCOMES: A CANADIAN PERSPECTIVE. CANADIAN JOURNAL OF OPHTHALMOLOGY, 59(1),.7¿11. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: A RETROSPECTIVE STUDY WAS DONE TO ANALYZE THE VISUAL OUTCOMES OF KAMRA (ACUFOCUS INC) INLAY INSERTION IN A COHORT OF PATIENTS REPORTING SUCCESS OF PROCEDURE, COMPLICATIONS, PATIENT SATISFACTION, AND REFRACTIVE OUTCOMES. A TOTAL OF 35 PATIENTS UNDERWENT KAMRA INLAY INSERTION. THERE WERE 9 PATIENTS WITH A SOLE KAMRA INLAY INSERTION, 15 HAD COMBINED LASER VISION CORRECTION (LVC) AND KAMRA INLAY INSERTION ON THE SAME DAY, AND 11 HAD SEQUENTIAL LVC AND KAMRA INLAY INSERTION. THE INTRALASE FEMTOSECOND LASER (ADVANCED MEDICAL OPTICS INC.), WAS USED TO CREATE A LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK) FLAP WHILE LVC ABLATION WAS PERFORMED WITH THE ISX STAR S4 IR LASER (JOHNSON & JOHNSON VISION) ON PATIENTS WHO UNDERWENT SIMULTANEOUS CONSECUTIVE LVC AND KAMRA INLAY INSERTION. POSTOPERATIVE COMPLICATIONS REPORTED INCLUDE STRIAE (N=1 PATIENT), EPITHELIAL INGROWTH (N=1 PATIENT), AND LATE-ONSET ECTASIA (N=2 PATIENTS). PATIENTS WHO UNDERWENT ENHANCEMENT INCLUDE 8 THAT UNDERWENT LASIK, 1 PHOTOREFRACTIVE KERATECTOMY, AND 2 CROSS-LINKING VIA THE DRESDEN PROTOCOL. THIS REPORT IS AGAINST THE STAR LASER. A SEPARATE REPORT WILL BE FILED AGAINST THE INTRALASE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257098 STAR S4 IR EXCIMER LASER SYSTEM LZS AMO MANUFACTURING USA, LLC UNK-EXCIMER 05050474573413

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention