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	09/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The ct lucia 602 lens was initially implanted using the yamane technique.However, the surgeon encountered difficulty centering the lens and ultimately had to explant it and replace it with another style of lens.The lens was not damaged prior to insertion, and no complications occurred during the procedure.Discovisc viscoelastic was used.The surgery proceeded as planned, and the patient is reported to be doing well post-operatively.
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.Most possible root cause.Off label use: the yamane technique requires precise execution, particularly in creating and positioning the scleral tunnels to anchor the haptics.Since this technique is off-label for the ct lucia 602 lens, achieving optimal centration can be more challenging.While the lens was not damaged prior to insertion, the design of the ct lucia 602 is not ideally suited for use with the yamane technique, which could have led to the centering issues observed during the procedure.

• 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: 20463480
• Report Number: 3010126268-2024-00095
• Device Sequence Number: 7765079
• Product Code: HQL
• UDI-Device Identifier: 00843045100935
• UDI-Public: (01)00843045100935(17)260831
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 10/16/2024

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: 08/31/2026
• Device Model Number: 602
• Device Catalogue Number: 003500-0050-672
• Device Lot Number: 3S210999
• 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: 09/19/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2021
• 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