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

Model Number	621P
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lens is not currently available for investigation, a proper device analysis could not be completed, or a wrong diopter confirmed.Factors that may or could have contributed to the refractive issue are (but not limited to): incorrect positioning of the lens inside the eye (decentration or lens placed upside down); selection of incorrect iol regarding refractive power; iol properties; patient pathology/ eye characteristics changes that can be caused by previous surgeries.Surgical technique.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.
Event or Problem Description
It was reported that a patient underwent iol operation using a ct lucia 621p on (b)(6) 2024.The hospital predicted a post-surgery result close to 0, but the actual result was around -1.5 myopia, necessitating a lens power exchange.The lens replacement was carried out on (b)(6) 2024.

• 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: 19766988
• Report Number: 3010126268-2024-00076
• Device Sequence Number: 18271076
• Product Code: HQL
• UDI-Device Identifier: 00843045102281
• UDI-Public: (01)00843045102281(11)230612(17)260531
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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: 05/31/2026
• Device Model Number: 621P
• Device Catalogue Number: 003500-0034-724
• Device Lot Number: 3S230703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2023
• 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