BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT LUCIA

    MDR report key: 23594400 · Received November 19, 2025

    Report

    Report Number
    3010126268-2025-00046
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    April 14, 2025
    Report Date
    November 20, 2025
    Manufacturer
    CARL ZEISS MEDITEC PRODUCTION LLC
    Product Code
    HQL
    UDI-DI
    00843045100997
    PMA / PMN Number
    P100016 S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMITIES OR DEVIATIONS NOTED DURING THE MANUFACTURING OF THE LENS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE NATURE OF THIS COMPLAINT. ADDITIONALLY, OUR LENSES ARE 100% INSPECTED BEFORE THEY LEAVE OUR MANUFACTURING SITE. THEREFORE, WE ARE CONFIDENT THAT THE LENS WAS PROCESSED PER STANDARD OPERATING PROCEDURES AND INSPECTIONS AND HAVE MET ALL CRITERIA FOR RELEASE. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR CT LUCIA 602 LENS, AND OUR EXPERIENCE, WE HAVE DETERMINED THAT THE FOLLOWING FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE (BUT NOT LIMITED TO): - LENS PLACEMENT TECHNIQUE. - LOADING STRATEGY. - ACCESSORY DEVICE SUPPORT. - POOR HANDLING DURING FOLDING AND INSERTING.

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF CHANGES: FIELD B4: ADDED "DATE OF THIS REPORT" 11/20/2025. FIELD G3: ADDED "DATE RECEIVED BY MANUFACTURER" 11/19/2025. FIELD G4: CORRECTED "PMA/510(K) NUMBER" FROM "P10016-S022" TO "P100016 S022". FIELD G6: CHECKED "30 DAYS", UPDATED TO "FOLLOW-UP, # 1". FIELD H2: CHECKED "CORRECTION". FIELD H11: ADDED DESCRIPTION OF CHANGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE HAPTIC ON THE CT LUCIA 602 DIDN'T GO ALL THE WAY INTO THE EYE AND WAS CATCHING ON THE IRIS. THE SURGEON CUT IT OUT AND USED A BACKUP CT LUCIA 602 LENS. THIS WAS NOT A HAPTIC ROTATION AND SIMPLY AN ERROR DURING INJECTION. NO NEGATIVE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2325617 CT LUCIA CT LUCIA 602 HQL CARL ZEISS MEDITEC PRODUCTION LLC 602 3S201403 00843045100997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention