BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT LUCIA 602

    MDR report key: 15857022 · Received November 23, 2022

    Report

    Report Number
    3010126268-2022-00028
    Event Type
    Injury
    Date Received
    November 23, 2022
    Date of Event
    October 26, 2022
    Report Date
    November 23, 2022
    Manufacturer
    CARL ZEISS MEDITEC PRODUCTION LLC
    Product Code
    HQL
    UDI-DI
    00843045100904
    PMA / PMN Number
    P100016-S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT, AND DEVICE INFORMATION. THIS REPORT WILL ALSO CAPTURE UDI# (B)(4), MATERIAL 003500-0050-674. IT WAS REPORTED THAT ON (B)(6) 2022 A CT LUCIA 602 LENS, WAS IMPLANTED INVERTED IN THE EYE. THE SURGEON EXPLANTED THE LENS. ANOTHER CT LUCIA 602 WAS WASTED BECAUSE THE DOCTOR NEEDED TO SECURE THE BAG SO THE IOL WAS REMOVED. CAPSULAR TENSION RING AND SEGMENT PUT IN. IT WAS STATED THAT THE JOINT BETWEEN THE OPTIC AND HAPTIC WAS LOOSE ALLOWING FOR HAPTICS TO FREELY ROTATE. NO ADDITIONAL INFORMATION PROVIDED. THE DEVICE HAS NOT BEEN RETURNED YET. 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. IT WAS REPORTED THAT 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. WE HAVE REVIEWED THE INFORMATION PROVIDED AND AT THIS TIME THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE MANUFACTURING, DESIGN, OR LABELING OF THE DEVICE. IT APPEARS THAT THE REPORTED ISSUE IS LINKED TO USER ERROR. HOWEVER, THE NEED TO EXPLANT THE LENS IS CONSIDERED NEED FOR MEDICAL INTERVENTION IN ORDER TO PREVENT AND AVOID PERMANENT IMPAIRMENT OR DAMAGE TO A BODY STRUCTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN IMPLANTING A CT LUCIA 602 THE HAPTIC BROKE. THE LENS WAS REMOVED, AND ANOTHER LENS WAS IMPLANTED HOWEVER DURING POST OP IT WAS NOTED THAT THE LENS HAD DISLOCATED. THE LENS WAS REMOVED, AND ANOTHER LENS WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354156 CT LUCIA 602 CT LUCIA 602 HQL CARL ZEISS MEDITEC PRODUCTION LLC 003500-0050-669 3S210262 00843045100904

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention