BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT LUCIA 602

    MDR report key: 15997359 · Received December 16, 2022

    Report

    Report Number
    3010126268-2022-00035
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    July 5, 2022
    Report Date
    December 16, 2022
    Manufacturer
    CARL ZEISS MEDITEC PRODUCTION LLC
    Product Code
    HQL
    UDI-DI
    00843045100935
    PMA / PMN Number
    P100016-S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MET ALL CRITERIA FOR RELEASE. THE DEVICE IS NOT BEING SENT BACK. THUS, A PROPER DEVICE ANALYSIS COULD NOT BE COMPLETED, NOR THE REPORTED ISSUES CONFIRMED. IT WAS MENTIONED BY THE CUSTOMER THAT THERE WAS NO DAMAGE NOTED DURING PREPARATION FOR USE INDICATING A PRODUCT QUALITY ISSUE DID NOT CONTRIBUTE TO THE REPORTED ISSUES. ADDITIONALLY, IT WAS STATED BY THE CUSTOMER THAT THEY ARE USING THE YAMANE TECHNIQUE TO IMPLANT THE LENSES. THIS TECHNIQUE INDUCES A LARGER AMOUNT OF FORCE WHILE TRYING TO POSITION THE HAPTICS IN THE SCLERAL TUNNEL. OUR LENSES ARE INTENDED TO BE IMPLANTED IN THE CAPSULAR BAG. IT WAS ALSO STATED THEY ARE USING AN EMARLD INJECTION SYSTEM. THUS, THE DEVICES ARE BEING USED OFF LABEL. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR THE LUCIA PRODUCT, AND BASED ON OUR EXPERIENCE AND OTHER COMPLAINTS THAT HAVE ALREADY BEEN RESOLVED, WE HAVE DETERMINED THAT THE FOLLOWING FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE DAMAGED HAPTIC AND IS NOT LIMITED TO: LOADING STRATEGY; LENS PLACEMENT TECHNIQUE; ACCESSORY DEVICE SUPPORT; POOR HANDLING DURING FOLDING AND INSERTING.

    Additional Manufacturer Narrative · 0

    G4: ADDED PMA/510(K) NUMBER P100016-S008.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CT LUCIA 602 LENS WAS EXPLANTED BECAUSE THE IOL WAS FOUND TO TILT PERPENDICULAR TO THE IRIS PLANE AFTER USING THE YAMANE TECHNIQUE. ANOTHER SPARE LENS WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2708837 CT LUCIA 602 CT LUCIA 602, PRODUCT CODE: HQL, PRODUCT CODE: HQL HQL CARL ZEISS MEDITEC PRODUCTION LLC 003500-0050-672 00843045100935

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention