BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOL MASTER 700

    MDR report key: 20195051 · Received September 11, 2024

    Report

    Report Number
    9615030-2024-00020
    Event Type
    Injury
    Date Received
    September 11, 2024
    Report Date
    September 11, 2024
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    UDI-DI
    04049471092080
    PMA / PMN Number
    K173771
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE POST-OP REFRACTION WAS FOUND TO BE OFF. MEDICAL INTERVENTION WAS NEEDED TO ADDRESS THE ISSUE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622891 IOL MASTER 700 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) 04049471092080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| R