BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT LUCIA

    MDR report key: 18862354 · Received March 7, 2024

    Report

    Report Number
    3010126268-2024-00030
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    February 12, 2024
    Report Date
    March 12, 2024
    Manufacturer
    CARL ZEISS MEDITEC PRODUCTION LLC
    Product Code
    HQL
    UDI-DI
    00843045100966
    PMA / PMN Number
    P10016-S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STATED THAT THE DEVICE CANNOT BE RETURNED THEREFORE A PROPER ROOT CAUSE ANALYSIS COULD NOT BE COMPLETED NOR THE REPORTED ISSUE CONFIRMED. WITHOUT A PROPER DEVICE ANALYSIS, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. 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. THUS, THE LENS WAS BEING USED OFF-LABEL. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR THE LUCIA PRODUCT, 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 POOR HANDLING DURING FOLDING AND INSERTING 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.

    Additional Manufacturer Narrative · 0

    FIELD B4: ADDED "DATE OF THIS REPORT" 03/12/2024. FIELD G4: CORRECTION: REMOVED " P10016-S008" FROM "DEVICE BLA" AND UPDATED "PMA/510(K)" WITH " P10016-S008". 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

    THE CUSTOMER REPORTED THAT THE HAPTICS WERE NOT STABLE AFTER PLACING IOL INTO THE EYE USING THE YAMANE TECHNIQUE. THE LENS HAD TO BE EXPLANTED AND REPLACED BY A DIFFERENT LENS. THE INCISION WAS ENLARGED IN ORDER TO EXPLANT THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990370 CT LUCIA CT LUCIA 602 HQL CARL ZEISS MEDITEC PRODUCTION LLC 602 00843045100966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention