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

Model Number	621P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the surgeon explanted the ct lucia 612p lens on (b)(6) 2026, due to bothersome arc light in periphery vision.No patient harm was reported.
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 by standard operating procedures and inspections and have met all criteria for release.There is no indication of a malfunction or deterioration in the characteristics or performance of the device.There is no evidence to indicate the presence of a potential quality issue with respect to the manufacture.The risk is covered in the product's risk analysis and ifu.Factors that may or could have contributed to the refractive issue are (but not limited to): incorrect positioning of the lens inside the eye (decentration or lens placed upside down).Selection of incorrect iol regarding refractive power.Iol properties.Patient pathology/eye characteristics changes that can be caused by previous surgeries.Surgical technique.

• 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: 25487713
• Report Number: 3010126268-2026-00032
• Device Sequence Number: 21312687
• Product Code: HQL
• UDI-Device Identifier: 00843045102342
• UDI-Public: (01)00843045102342(11)250131(17)271231
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100016 S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/29/2026

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: 003500-0056-488
• Device Lot Number: 3S250092
• 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: 06/03/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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