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

Model Number	621P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for return.Thus, a proper device analysis could not be completed, nor the reported issue confirmed.We have reviewed the device history records and sterilization records.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.There is no evidence to suggest a product quality issue with respect to manufacture, design, or labeling of the lens.Quality control confirmed that no failures of the following have occurred during the manufacturing period of these lenses: · bioburden · endotoxins on the product · particulate count in clean room · air born germs (clean room and laminar flow hoods) after reviewing the complaint information and discussing with our r&d team it was determined that the unidentified substance could possibly be but is not limited to be: · gms (glycerol monostearate) - which is an organic molecule used as a lubricant in the lucia product.Gms is incorporated into the tube during product manufacturing and is used to ease the delivery of the lens; however, it is nontoxic and known to dissipate over time.Gms has been used as a lubricant in iol insertion instruments for more than 25 years.Therefore, we are confident that this substance would not cause or contribute to any adverse patient effect.
Event or Problem Description
It was reported that a spot was observed on the ct lucia 621p intraocular lens (iol) after it was implanted into the eye.The surgeon explanted the lens and successfully implanted a new lens during the same surgery.

• 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 ; 9252164679
• MDR Report Key: 22734396
• Report Number: 3010126268-2025-00031
• Device Sequence Number: 7198469
• Product Code: HQL
• UDI-Device Identifier: 00843045102335
• UDI-Public: (01)00843045102335(11)230411(17)260331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100016-S017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 08/06/2025

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: 03/31/2026
• Device Model Number: 621P
• Device Catalogue Number: 003500-0056-487
• Device Lot Number: 3S230409
• 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: 07/11/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2023
• 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