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

Model Number	602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported, "one of our retina surgeons was trying to implant a ct lucia 602 17.5 diopter lens.The patient became uncooperative mid procedure, and the surgeon had to abort the implantation of the lens.At that point the lens was in the patient's eye, it was cut into several pieces and removed, and the patient was left aphakic.The lens was discarded.".
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, the risk assessment for the ct lucia 3-piece product, and our experience, we have determined that the following factors may have caused or contributed to the reported issue: · the uncooperative behavior of the patient during the procedure introduced an unexpected variable that disrupted the surgical process.This sudden movement likely created challenges for the surgeon in maintaining control and precision during the implantation, which ultimately led to the decision to abort the procedure to ensure patient safety.The need to cut the lens into pieces for removal and the subsequent aphakic state of the patient highlights the complexity and difficulty of managing intraoperative disruptions.While the ct lucia 3-piece lens is designed for controlled implantation, unanticipated patient movements can compromise surgical outcomes and require swift adjustments by the surgeon to mitigate risk and prevent further complications.

• 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: 20779201
• Report Number: 3010126268-2024-00104
• Device Sequence Number: 21095609
• Product Code: HQL
• UDI-Device Identifier: 00843045100881
• UDI-Public: (01)00843045100881(17)260630
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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: 06/30/2026
• Device Model Number: 602
• Device Catalogue Number: 003500-0050-667
• Device Lot Number: 3S210806
• 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: 11/04/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2021
• 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