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	09/22/2025
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.The device can not be returned therefore a proper root cause analysis could not be completed nor the reported issue confirmed.Without a proper device analysis, a definitive root cause cannot be determined at this time.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.
Event or Problem Description
It was reported that a patient had a ct lucia 602 lens implanted using the yamane technique.After implantation, the lens subluxated inferiorly.It was exchanged during the same surgery with an anterior chamber iol (intraocular lens).No negative patient impact was reported.
Additional Manufacturer Narrative
Description of changes: field b4: added "date of this report" 3/31/2026.Field g3: updated "date received by manufacturer" to "3/18/2026".Field g6: checked "30 days"", updated to "follow-up, # 1".Field h2: checked "device evaluation".Field h3: updated "device evaluated by manufacturer?" to "yes".Field h6: added "type of investigation" code 10.Field h11: added description of changes.File attachments: attached device evaluation.

• 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: 24309871
• Report Number: 3010126268-2026-00004
• Device Sequence Number: 9471337
• Product Code: HQL
• UDI-Device Identifier: 00843045100959
• UDI-Public: (01)00843045100959(17)300331
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: 003500-0050-674
• Device Lot Number: 30/11/2029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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