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

Model Number	602
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no damage reported to have been noticed during the inspection prior to use and preparation, which suggests that a product deficiency did not contribute to the reported difficulties.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: -lens placement technique -loading strategy -accessory device support -poor handling during folding and inserting 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 doctor was unable to center a ct lucia 602.The iol was removed and a new lens was implanted successfully.
Additional Manufacturer Narrative
Description of changes: field d9: updated to "yes".Field g3: updated "date received by manufacturer".Field g6: updated to "follow-up, 30-day, # 1".Field h2: selected "device evaluation".Field h3: updated to "yes".Field h6: added "type of investigation" code "10".Added "investigation conclusions" code "18" and "4310".Field h10: added description of changes.

• 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: 18567472
• Report Number: 3010126268-2024-00016
• Device Sequence Number: 12465299
• Product Code: HQL
• UDI-Device Identifier: 00843045100904
• UDI-Public: (01)00843045100904(17)251031
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P100016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 02/06/2024

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: 10/31/2025
• Device Model Number: 602
• Device Lot Number: 3S201520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2020
• 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; Death
• Patient Sex: Unknown