BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE PRO

    MDR report key: 20102153 · Received August 29, 2024

    Report

    Report Number
    3012236936-2024-000240
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    August 8, 2024
    Report Date
    September 24, 2024
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K151636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EQUIPMENT PRESENTS LOW IRRIGATION AND DIFFICULTY IN ASPIRATION WHICH CAUSED THE PATIENT TO HAVE CORNEAL EDEMA. IT WAS ALSO REPORTED PATIENT HAD CORNEAL BURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910971 WHITESTAR SIGNATURE PRO UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC NGP680301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other