BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IOLMASTER 700

    MDR report key: 18545142 · Received January 19, 2024

    Report

    Report Number
    9615030-2024-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    December 11, 2023
    Report Date
    January 19, 2024
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K170171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF CHANGES: FIELD D4: UPDATED MODEL NUMBER TO "700". FIELD D4: UPDATED CATALOG NUMBER TO "000000-1932-169". FIELD G6: UPDATED TO "FOLLOW-UP, # 1". FIELD H2: CHECKED "CORRECTION". FIELD H4: UPDATED TO "01MAR2016". FIELD H6: UPDATED COMPONENT CODE TO "593".

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEY ARE GETTING HIGH AXIAL LENGTH (AL) MEASUREMENTS WHICH HAS LED TO INCORRECT IOL CALCULATIONS. THEY WERE COMPARING ALS TO ANOTHER IOLMASTER. NO PATIENT HARM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211090 IOLMASTER 700 IOLMASTER 700 HJO CARL ZEISS MEDITEC AG (JENA) 700

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown