BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESCAN 700

    MDR report key: 21753492 · Received April 2, 2025

    Report

    Report Number
    9615010-2025-00003
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    January 23, 2025
    Report Date
    April 2, 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

    CORRECTED DATA: A1: ADDED PT BANAEE. B3: CORRECTED DATE OF EVENT FROM 3/04/2025 TO 1/23/2025.

    Description of Event or Problem · 0

    A DOCTOR REPORTED THAT AFTER A VITRECTOMY SURGERY WITH RESCAN 700 (USING TISSUEBLUE), 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
    2301815 RESCAN 700 RESCAN 700 OBO CARL ZEISS MEDITEC AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability