BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT LUCIA

    MDR report key: 23139933 · Received September 24, 2025

    Report

    Report Number
    3010126268-2025-00040
    Event Type
    Injury
    Date Received
    September 24, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 24, 2025
    Manufacturer
    CARL ZEISS MEDITEC PRODUCTION LLC
    Product Code
    HQL
    PMA / PMN Number
    P100016 S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEWING THE MANUFACTURING DOCUMENTS DID NOT SHOW ANY INDICATIONS FOR A MALFUNCTION OF THE IOL. AS PER DOCUMENTATION, THE PRODUCT WAS PRODUCED IN ACCORDANCE WITH MANUFACTURER'S SPECIFICATION AND NO DEVIATION HAS BEEN DETECTED. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR THE LUCIA PRODUCT, AND BASED ON OUR EXPERIENCE, WE HAVE DETERMINED THAT THE FOLLOWING FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DEVICE DEFICIENCY BUT ARE NOT LIMITED TO: INCOMPLETE OR IMPROPER LOADING OF THE DEVICE: DURING THE LOADING PROCESS, THE DEVICE REQUIRES A TACTILE "CLICK" TO CONFIRM PROPER ADVANCEMENT INTO THE CORRECT POSITION. THE ABSENCE OF THIS "CLICK" SUGGESTS THAT THE DEVICE MAY NOT HAVE BEEN FULLY SEATED OR ALIGNED WITHIN THE CARTRIDGE. MISALIGNMENT OR INCOMPLETE ADVANCEMENT COULD PREVENT THE DEVICE FROM FUNCTIONING AS INTENDED DURING PREPARATION. POTENTIAL INSUFFICIENT OVD APPLICATION: WHILE THE SITE INDICATES THAT OVD WAS APPLIED DURING PREPARATION, IT IS CRITICAL TO ENSURE THAT A GENEROUS AMOUNT OF OVD IS APPLIED TO BOTH THE LENS AND THE CARTRIDGE. IF OVD IS INADEQUATELY OR UNEVENLY APPLIED, IT MAY RESULT IN INCREASED FRICTION DURING THE ADVANCEMENT PROCESS, LEADING TO INCOMPLETE POSITIONING OF THE DEVICE AND PREVENTING THE TACTILE "CLICK." VARIABILITY IN HANDLING OR TECHNIQUE: VARIABILITY IN THE SURGICAL TECHNICIAN'S HANDLING TECHNIQUE DURING DEVICE PREPARATION COULD HAVE CONTRIBUTED TO THE REPORTED DEFICIENCY. FOR INSTANCE, IF THE PLUNGER WAS NOT ADVANCED SMOOTHLY OR AT THE CORRECT ANGLE, IT COULD LEAD TO INCOMPLETE ADVANCEMENT OF THE DEVICE, RESULTING IN THE ABSENCE OF THE TACTILE "CLICK" AND SUBSEQUENT DEVICE MALFUNCTION. DWELL TIME OR DELAYED INJECTION: ALTHOUGH THE DEVICE WAS NOT USED AND THE ISSUE OCCURRED DURING PREPARATION, PROLONGED DWELL TIMES IN INTERMEDIATE POSITIONS COULD THEORETICALLY IMPACT DEVICE PERFORMANCE. IF THE LENS IS ADVANCED INTO THE CONICAL SECTION BUT NOT IMMEDIATELY INJECTED, THE VISCOELASTIC MATERIALS MAY LOSE THEIR LUBRICITY, POTENTIALLY EXACERBATING ANY ISSUES DURING DEVICE ADVANCEMENT.

    Description of Event or Problem · 0

    THE SURGEON STARTED TO INJECT THE ZEISS CT LUCIA 621P INTRAOCULAR LENS (IOL) INTO THE CAPSULAR BAG WHEN HE REALIZED THE HAPTIC WAS STUCK UNDER THE PLUNGER. AFTERWARDS, THE HAPTIC WAS TORN OFF THE OPTIC. THE SURGEON WAS ABLE TO USE ANOTHER CT LUCIA FROM THE CONSIGNMENT STOCK THUS THE SURGICAL PROCESS WAS FINISHED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850322 CT LUCIA CT LUCIA 621P HQL CARL ZEISS MEDITEC PRODUCTION LLC 621P 3S240388

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention