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

Model Number	602
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided and our experience with the lucia product, the following factors may have caused or contributed to the reported issue of a defective haptic: off-label use of injector system: the ct lucia 602 iol is designed for use exclusively with a zeiss injector system.In this case, the lens was inserted using a blue monarch injector with a b cartridge, which constitutes off-label use.The use of a non-zeiss injector system may have resulted in suboptimal compatibility, leading to increased friction and resistance during lens delivery.When an injector system is not specifically designed for a particular iol, variations in cartridge dimensions, plunger force distribution, and lubrication dynamics can create conditions where the lens does not advance smoothly.This likely necessitated the application of excessive force to deploy the iol, increasing mechanical stress on the haptics and leading to the observed bending upon release.Insertion resistance during lens delivery: the surgeon noted that the lens did not advance easily out of the plunger and required additional force for deployment.This aligns with known risks associated with the use of an incompatible injector system, where mismatches in dimensions or material interactions can create high resistance during delivery.Increased force applied to overcome this resistance may have subjected the haptics to unintended stress, causing deformation upon emergence from the injector tip.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
During the lens implantation, the lens had difficulty advancing during delivery.Post-implantation, the surgeon noted that the haptics were slightly bent.The lens was inserted using a blue monarch injector with a b cartridge, which is an off-label use.Despite adequate lubrication, increased friction and resistance required excessive force to advance the lens, likely leading to mechanical stress and bending of the haptics.The lens was later explanted, and no patient injury or surgical delay occurred.

• 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: 21364108
• Report Number: 3010126268-2025-00002
• Device Sequence Number: 8434741
• Product Code: HQL
• UDI-Device Identifier: 00843045100836
• UDI-Public: (01)00843045100836(17)270831
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P10016-S008
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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: 003500-0050-662
• Device Lot Number: 3S220890
• 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: 01/16/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2022
• 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