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	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer stated that the device can not be returned therefore a proper root cause analysis could not be completed.There was no damage reported to have been noticed during the inspection prior to use and preparation, which suggests a product deficiency did not contribute to the reported difficulties.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 kinked during implantation, 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.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
During a ct lucia 602 lens implantation procedure, the haptic became kinked.The device was explanted and a backup ct lucia 602 lens was implanted within the same surgery.The procedure was performed using a zeiss cartridge and injector system.The yamane technique was used during the procedure.The affected device is not returnable.No damage was noted during preparation or prior to loading the lens.No patient injury was reported.

• 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: 22841831
• Report Number: 3010126268-2025-00034
• Device Sequence Number: 4926980
• Product Code: HQL
• UDI-Device Identifier: 00843045100966
• UDI-Public: (01)00843045100966(17)280331
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100016 S019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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 Model Number: 602
• Device Catalogue Number: 003500-0050-675
• Device Lot Number: 3S230402
• 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: 07/31/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2023
• 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