BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT LUCIA 602

    MDR report key: 16030562 · Received December 21, 2022

    Report

    Report Number
    3010126268-2022-00053
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    October 20, 2022
    Report Date
    January 19, 2023
    Manufacturer
    CARL ZEISS MEDITEC PRODUCTION LLC
    Product Code
    HQL
    UDI-DI
    00843045100959
    PMA / PMN Number
    P100016-S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME IT IS UNKNOWN IF THE DEVICE IS BEING SENT BACK. THUS, A PROPER DEVICE ANALYSIS COULD NOT BE COMPLETED NOR THE REPORTED ISSUES CONFIRMED. 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. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA - B3: DATE OF EVENT 10/20/2022; B4: DATE OF THIS REPORT 1/19/2023; D4: MODEL #: CT LUCIA 602; CATALOG # 00350-0050-674; SERIAL # (B)(6); EXPIRATION DATE 04/30/2026; LOT # 3S210629; UNIQUE IDENTIFIER (UDI) # (B)(4); 6A: IMPLANTED DATE (B)(6) 2022; 6B: EXPLANTED DATE (B)(6) 2022. G3: DATE RECEIVED BY MANUFACTURER 12/22/2022; G6 TYPE OF REPORT: FOLLOW-UP #1; H2: IF FOLLOW-UP, WHAT TYPE: ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A CT LUCIA 602 EVERYTHING LOOKED GOOD, HOWEVER, THE IOL TILTED 90 DEGREES THE NEXT DAY. IT WAS BELIEVED THE ISSUE WAS DUE TO LARGE WTW. PATIENT WAS AROUND 12.7. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2864522 CT LUCIA 602 CT LUCIA 602, PRODUCT CODE: HQL, PRODUCT CODE: HQL HQL CARL ZEISS MEDITEC PRODUCTION LLC CT LUCIA 602 3S210629 00843045100959

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention