MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC CT LUCIA; CT LUCIA 621P

Model Number	621P
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/04/2026
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 provided, the risk assessment for the lucia product, and based on our experience, we have determined that the following factors may have caused or contributed to the reported device deficiency but are not limited to: -incomplete or improper loading of the device: during the loading process, the device requires a tactile "click" to confirm proper advancement into the correct position.The absence of this "click" suggests that the device may not have been fully seated or aligned within the cartridge.Misalignment or incomplete advancement could prevent the device from functioning as intended during preparation.-potential insufficient ovd application: while the site indicates that ovd was applied during preparation, it is critical to ensure that a generous amount of ovd is applied to both the lens and the cartridge.If ovd is inadequately or unevenly applied, it may result in increased friction during the advancement process, leading to incomplete positioning of the device and preventing the tactile "click." -variability in handling or technique: variability in the surgical technician's handling technique during device preparation could have contributed to the reported deficiency.For instance, if the plunger was not advanced smoothly or at the correct angle, it could lead to incomplete advancement of the device, resulting in the absence of the tactile "click" and subsequent device malfunction.-dwell time or delayed injection: although the device was not used and the issue occurred during preparation, prolonged dwell times in intermediate positions could theoretically impact device performance.If the lens is advanced into the conical section but not immediately injected, the viscoelastic materials may lose their lubricity, potentially exacerbating any issues during device advancement.The available information does not indicate abnormalities during preparation or manufacturing deviations.Based on this assessment, the observed deficiency appears to be isolated and related to handling or procedural variability during the preparation process.
Event or Problem Description
The customer reported that during surgery the haptic of the ct lucia 621p lens would not inject properly and the lens was partially implanted in the capsular bag.The lens was subsequently explanted and a spare zeiss lens was used to successfully complete the procedure.No patient injury was reported.

• Brand Name: CT LUCIA
• Common Device Name: CT LUCIA 621P
• 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 manjaya ; 5300 central parkway; dublin, CA 94568 ; 9255574259
• MDR Report Key: 25670072
• Report Number: 3010126268-2026-00034
• Device Sequence Number: 10407060
• Product Code: HQL
• UDI-Device Identifier: 00843045102281
• UDI-Public: (01)00843045102281(11)250611(17)280531
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100016S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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 Model Number: 621P
• Device Catalogue Number: 003500-0056-482
• Device Lot Number: 3S250610
• 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: 06/04/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2025
• 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: Required Intervention
• Patient Sex: Unknown