BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT LUCIA 602

    MDR report key: 16019990 · Received December 21, 2022

    Report

    Report Number
    3010126268-2022-00065
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    March 29, 2022
    Report Date
    December 20, 2022
    Manufacturer
    CT LUCIA 602, PRODUCT CODE: HQL, PRODUCT CODE: HQL
    Product Code
    HQL
    PMA / PMN Number
    P100016-S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. THUS, THE LENS IS 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 FACTOR MAY HAVE CAUSE OR CONTRIBUTED TO THE DAMAGED HAPTIC IS BUT IS NOT LIMITED TO: LOADING STRATEGY. LENS PLACEMENT TECHNIQUE. ACCESSORY DEVICE SUPPORT . 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 MET ALL CRITERIA FOR RELEASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER IS PERFORMING YAMANE SINCE 2019. CUSTOMER REPORTED THAT THEY HAD A CASE OF ABNORMAL ANGULATION OF THE HAPTIC. LENS WAS REMOVED AND A COMPETITOR LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457375 CT LUCIA 602 CT LUCIA 602, PRODUCT CODE: HQL, PRODUCT CODE: HQL HQL CT LUCIA 602, PRODUCT CODE: HQL, PRODUCT CODE: HQL 003500-0050-673 3S210247

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention