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

Model Number	621 P
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reviewing the manufacturing documents did not show any indications for a malfunction of the iol.As per documentation, the product was produced in accordance with manufacturer's specification, and no deviation has been detected.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.As the device is not yet available, it is not possible to conclude more precisely on the root cause of this complaint.
Event or Problem Description
It was reported that half of the ct lucia 621p intraocular lens (iol) was implanted into the patient's eye and the other half (haptic) remained stuck in the injector.The iol was successfully removed from the patient's eye.The surgeon had a replacement lens available to complete the surgery.The patient was reported to be fine.
Additional Manufacturer Narrative
Description of changes: field d9: updated to "yes" field g3: updated "date received by manufacturer" to "04/08/2026".Field g6: updated to "follow-up # 1 and 30-day" field h2: selected "additional information, and device evaluation" field h3: updated to "yes".Checked "evaluation summary attached" box field h6: added "type of investigation" code 10, testing of actual/suspect device.Field h11: added description of changes.Attached the evaluation summary.

• 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 hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 24393029
• Report Number: 3010126268-2026-00009
• Device Sequence Number: 10504258
• Product Code: HQL
• UDI-Device Identifier: 00843045102328
• UDI-Public: (01)00843045102328(11)250218(17)280131
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100016 S022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: 621 P
• Device Catalogue Number: 003500-0056-486
• Device Lot Number: 3S250160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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