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

Model Number	621P
Medical Device Problem Codes	Use of Device Problem (1670); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device is not available, a proper device analysis could not be completed nor the reported issue confirmed.A query was completed in our complaint system and no other similar complaints linked to this specific lot were found, indicating no systemic manufacturing or quality issue with the device.There two main causes for zonular instability and capsular compromise: predisposing lens and patient factors that make the zonules weak and capsule fragile.Inadequate surgical maneuvers that produce anatomical conditions.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.
Event or Problem Description
It was reported that following implantation of the ct lucia 621p iol (intraocular lens), the patient was referred to a retina specialist due to zonular instability.It was further reported that the lens must be removed because the compromised capsular bag was unstable and could not support any one-piece lens (ct lucia 621p), which is unrelated to the device itself.The secondary surgery will involve a lens exchange by a retina doctor, who will suture a three-piece iol in place.No retinal pathologies have been identified, and the patient is now under the care of another physician for this procedure.

• 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: 22912528
• Report Number: 3010126268-2025-00036
• Device Sequence Number: 9184740
• Product Code: HQL
• UDI-Device Identifier: 00843045102335
• UDI-Public: (01)00843045102335(11)230422(17)260331
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: 03/31/2026
• Device Model Number: 621P
• Device Catalogue Number: 003500-0056-487
• Device Lot Number: 3S230458
• 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: 08/06/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2023
• 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