BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESCAN 700

    MDR report key: 21753839 · Received April 2, 2025

    Report

    Report Number
    9615010-2025-00004
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    February 20, 2025
    Report Date
    April 3, 2025
    Manufacturer
    CARL ZEISS MEDITEC AG
    Product Code
    OBO
    PMA / PMN Number
    K141844
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO DEVICE MALFUNCTION THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED INCIDENT. THE DEVICE WAS DESIGNED AND MANUFACTURED IN ACCORDANCE WITH THE CORRESPONDING LIMITS ACCORDING TO STANDARDS ISO/DIS 10936-2:2010 AND ISO 15004-2:2007, IEC 62471:2006, INCLUDING THE INSTALLATION OF AN ADEQUATE FILTER, ESPECIALLY FOR THE UV/IR RANGE, WHICH PREVENTS ANY LIGHT HAZARD FROM OPERATING MICROSCOPES USED IN OCULAR SURGERY.

    Additional Manufacturer Narrative · 0

    A1: ADDED PT ELANNAN. B5: REMOVED "(USING TISSUEBLUE)" FROM DESCRIPTION. E4: CHANGED FROM NO, TO UNKNOWN.

    Description of Event or Problem · 0

    A DOCTOR REPORTED THAT AFTER A VITRECTOMY SURGERY WITH RESCAN 700 (USING TISSUE BLUE), PATIENT EXPERIENCED RETINAL WHITENING AND VISION LOSS. PATIENT WAS REPORTED TO HAVE SUFFERED PERMANENT INJURY.

    Description of Event or Problem · 0

    A DOCTOR REPORTED THAT AFTER A VITRECTOMY SURGERY WITH RESCAN 700, PATIENT EXPERIENCED RETINAL WHITENING AND VISION LOSS. PATIENT WAS REPORTED TO HAVE SUFFERED PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744763 RESCAN 700 RESCAN 700 OBO CARL ZEISS MEDITEC AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability