MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC CT LUCIA; CT LUCIA 602

Model Number	602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Based on the information, this kind of inflammatory reaction(endophthalmitis) could be caused by multiple factors and may be related to patient condition (diseases) or other external influences (surgical technique, other used components e.G.Ovd).With the information we've received and after reviewing the manufacturing documents, which did not show an indication of a malfunction of the iol causing or contributing to the reported incident, we can confirm that the product has been produced in accordance with manufacturer's specification and no deviation has been detected.
Event or Problem Description
It was reported that after surgery the patient developed endophthalmitis.The surgery was performed on (b)(6) 2025 - pars plana vitrectomy and insertion of intraocular lens.On (b)(6) 2025, the patient was diagnosed with endophthalmitis and had a vitreous tap and injection of vancomycin and ceftazidime.Cultures so far show no growth.The patient had a follow up visit on (b)(6) 2025 and showed improvement in symptoms and on exam.There are plans for continued close follow ups.

• Brand Name: CT LUCIA
• Common Device Name: CT LUCIA 602
• Manufacturer (Section D): CARL ZEISS MEDITEC PRODUCTION LLC; 1040 s. vintage ave. bld. a; ontario CA 91761
• Manufacturer (Section G): CARL ZEISS MEDITEC PRODUCTION LLC; 1040 s. vintage ave. bld. a; ontario CA 91761
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 23632099
• Report Number: 3010126268-2025-00050
• Device Sequence Number: 10291481
• Product Code: HQL
• UDI-Device Identifier: 00843045100881
• UDI-Public: (01)00843045100881(17)260731
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100016 S022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 602
• Device Catalogue Number: 003500-0050-667
• Device Lot Number: 3S210972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown