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

Model Number	602
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the risk assessment for the lucia 3-piece product, and our experience, we have determined that the following factor may have caused or contributed to the reported issue: off-label use of the yamane technique: the ct lucia 602 lens is not validated for use with the yamane scleral fixation technique.This off-label method introduces rotational forces and anchoring dynamics that are not accounted for in the design specifications of the lens.In this case, the surgeon reported the haptic was damaged during lasering at the optic-haptic junction, which ultimately required explantation.The haptics, while ideal for traditional in-the-bag implantation, may not provide the necessary resistance or stability when fixated externally via the yamane technique.The product was manufactured according to specifications, and no product-related deficiency was identified.The reported failure is attributable to off-label handling, not a product malfunction.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 by standard operating procedures and inspections and have met all criteria for release.
Event or Problem Description
It was reported that a ct lucia 602 lens was implanted but was tilted and doctor could not get the lens to lay flat.Yamane technique was used.The lens was removed and replaced with another.There was no patient harm reported.
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 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: 23630042
• Report Number: 3010126268-2025-00048
• Device Sequence Number: 9337594
• Product Code: HQL
• UDI-Device Identifier: 00843045101079
• UDI-Public: (01)00843045101079(17)270731
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100016 S022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 04/10/2026

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: 602
• Device Catalogue Number: 003500-0050-686
• Device Lot Number: 3S220766
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2022
• 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