BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE

    MDR report key: 20970690 · Received December 18, 2024

    Report

    Report Number
    3012236936-2024-000324
    Event Type
    Injury
    Date Received
    December 18, 2024
    Report Date
    December 18, 2024
    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

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION B3 - DATE OF EVENT: EXACT DATE NOT PROVIDED. SECTION D4 - SERIAL NUMBER: UNKNOWN/ NOT PROVIDED. SECTION D4 - UDI NUMBER: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: NOT APPLICABLE. THE MACHINE IS NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE. THE MACHINE IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. E1 NAME - BERIRE SEYMA DURMUS ECE - CORRESPONDING AUTHOR SECTION H3: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4 - DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: BERIRE S ¸EYMA DURMUS¸ ECE; IMMEDIATE SEQUENTIAL BILATERAL CATARACT SURGERY IS A REASONABLE AND SAFE OPTION DURING A PANDEMIC; JOURNAL FRANÇAIS D¿OPHTALMOLOGIE 46 (2023) 742¿749; DOI: 10.1016/J.JFO.2022.12.028. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: IMMEDIATE SEQUENTIAL BILATERAL CATARACT SURGERY IS A REASONABLE AND SAFE OPTION DURING A PANDEMIC. A STUDY WAS DONE TO EVALUATE THE PREOPERATIVE AND INTRAOPERATIVE FEATURES, INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS AND POSTOPERATIVE SATISFACTION OF PATIENTS WHO UNDERWENT IMMEDIATE SEQUENTIAL BILATERAL CATARACT SURGERY (ISBCS) DURING THE COVID-19 PANDEMIC. A TOTAL OF 206 EYES OF 103 PATIENTS UNDERWENT ISBCS. PHACOEMULSIFICATION WAS PERFORMED BY USING THE WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM (AMO, INC.) AND THE PATIENTS WERE IMPLANTED WITH THE INTRAOCULAR LENS (IOL) SENSAR®MONOFOCAL 1-PIECE IOL (JOHNSON & JOHNSON SURGICAL VISION). TWO PATIENTS UNDERWENT ANTERIOR VITRECTOMY (N=2 EYES) AND SULCUS IOL PLACEMENT DUE TO POSTERIOR CAPSULE RUPTURE (N=2 EYES) COMBINED WITH VITREOUS LOSS (N=2 EYES)." THIS ISSUE OCCURRED TWICE WITH TWO DIFFERENT PATIENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER PATIENT INVOLVED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022960 WHITESTAR SIGNATURE UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other SENSAR®MONOFOCAL 1-PIECE IOL