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

Model Number	602
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported that after a ct lucia 602 lens had been implanted, the doctor noticed that it had a defect.An indentation or crease along the lens was noticed.The doctor promptly removed the lens and replaced with another one.No additional information was provided.
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.Based on the information provided, including the device history record, risk assessment for the lucia 3-piece iol, and our experience, the following factors may have caused or contributed to the reported issue: improper handling: the lens may have been mishandled during the surgical process, leading to the indentation or crease observed in the lens.This could occur during the loading of the lens into the injector or during implantation.Injector misalignment: the lens could have been improperly loaded into the injector, causing the crease or indentation when the lens was advanced through the injector.Surgical technique: the surgical technique used during implantation may have contributed to the lens deformity, particularly if excessive force was applied or if the instrument used was not aligned correctly.Given that the device is not yet received not available for evaluation, the exact cause cannot be definitively determined, but the factors above are considered the most likely contributors.
Additional Manufacturer Narrative
Description of changes: field b4: added "date of this report" 09/12/2024.Field g6: checked "30 days", updated to "follow-up, # 1".Field h2: checked "correction." field h11: added description of changes.

• Brand Name: CT LUCIA
• Common Device Name: CT LUCIA 602
• Manufacturer (Section D): CARL ZEISS MEDITEC PRODUCTION LLC; carl zeiss meditec production; 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 manjaya ; 5300 central parkway; dublin, CA 94568 ; 9255574259
• MDR Report Key: 20204391
• Report Number: 3010126268-2024-00087
• Device Sequence Number: 7649583
• Product Code: HQL
• UDI-Device Identifier: 00843045100935
• UDI-Public: (01)00843045100935(17)271031
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P10016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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: 003500-0050-672
• Device Lot Number: 3S221133
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2022
• 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