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

Model Number	621P
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned.Thus, a proper device analysis could not be completed nor the reported issue confirmed.At this time, without a proper device analysis, a definitive root cause cannot be determined.However, there is no indication of a product quality issue with respect to manufacturing, design, or labeling of the lens.Based on the information provided, the risk assessment for the lucia product, and our experience we have determined that the following factors may have cause or contributed to the reported issue is but is not limited to: -misplacement of the lens -inadequate application of ovd -dwell time after preparation 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.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 met all criteria for release.
Event or Problem Description
It was reported that the lens was not deploying correctly, which was in the opposite direction than normal.The lens was injected into the eye partially and then had to be removed.

• 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: 19129694
• Report Number: 3010126268-2024-00046
• Device Sequence Number: 4658154
• Product Code: HQL
• UDI-Device Identifier: 00843045102373
• UDI-Public: (01)00843045102373(11)230215(17)260131
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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 Expiration Date: 01/31/2026
• Device Model Number: 621P
• Device Catalogue Number: 003500-0056-491
• Device Lot Number: 3S230173
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2023
• 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