BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHACO MACHINE WHITESTAR SIGNATURE SYSTEM

    MDR report key: 12925660 · Received December 3, 2021

    Report

    Report Number
    3012236936-2021-00110
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    May 5, 2020
    Report Date
    December 3, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE WAS APPROVED ON MAY 05, 2020. CITATION: MEHMED UGUR ISIK, M. & F. YALCINDAG, N. (2020). COMPARISON OF THE EFFICACY OF NEPAFENAC 0.1% IN QUIESCENT BEHCET¿S UVEITIS AND NON-UVEITIC HEALTHY PATIENTS AFTER PHACOEMULSIFICATION SURGERY. SPRINGER NATURE B.V. 2020. INT OPHTHALMOL (2020) 40:2345¿2351. THE PHACO MACHINE WHITESTAR SIGNATURE SYSTEM IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE COULD NOT BE PERFORMED AS THE SERIAL NUMBER HAS NOT BEEN PROVIDED. 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: ARTICLE: COMPARISON OF THE EFFICACY OF NEPAFENAC 0.1% IN QUIESCENT BEHCET'S UVEITIS AND NON-UVEITIC HEALTHY PATIENTS AFTER PHACOEMULSIFICATION SURGERY. A RETROSPECTIVE CONSECUTIVE CASE SERIES STUDY WAS DONE TO COMPARE THE EFFICACY OF NEPAFENAC ON ANTERIOR CHAMBER FLARE AND INTRAOCULAR PRESSURE (IOP) IN HEALTHY (GROUP 1) AND UVEITIC EYES (GROUP 2) UNDERGOING CATARACT SURGERY. A TOTAL OF 54 PATIENTS UNDERWENT CATARACT SURGERY AND WERE DIVIDED INTO TWO GROUPS: GROUP 1 (PATIENTS WITH HEALTHY EYES; N=40) AND GROUP 2 (PATIENTS WITH HISTORY OF UVEITIS; N=14). ALL PATIENTS UNDERWENT CATARACT SURGERY WITH THE DIVIDE-CONQUER TECHNIQUE USING THE WHITESTAR SIGNATURE PHACOEMULSIFICATION (ABBOTT MEDICAL OPTICS INC.) DEVICE THROUGH A 2.8 MM CLEAR CORNEAL INCISION. THE SAME OPHTHALMIC VISCOSURGICAL DEVICE (SODIUM HYALURONATE 1.4%, HEALON GV) AND ACRYLIC IOL (AR40E, ABBOTT MEDICAL OPTICS, INC.) WERE USED IN ALL PATIENTS. ALL PATIENTS DEVELOPED ANTERIOR CHAMBER FLARE (N=54). INTERVENTIONS INCLUDE ADMINISTRATION OF NEPAFENAC 0.1%, DEXAMETHASONE 0.1% AND CIPROFLOXACIN 0.3%. NO FURTHER INFORMATION HAS BEEN PROVIDED OR IT IS AVAILABLE. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825190 PHACO MACHINE WHITESTAR SIGNATURE SYSTEM UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown