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	09/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the 621p lens was inserted in the eye by the doctor.A broken haptic was observed.The lens with the broken haptic was removed from the eye during the same surgery.Device will not be returned.
Additional Manufacturer Narrative
Based on the information provided and the risk assessment for the ct lucia 621p lens, the following factors may have contributed to the reported issue of the broken haptic, but are not limited to: -improper handling during surgery: even though no damage was noted during preparation, it is possible that the haptic could have been damaged during the surgical process.Variability in surgical techniques or handling of the preloaded injector system may have contributed to the haptic breaking during the implantation.-excessive force during injection: the broken haptic may have resulted from excessive force or improper technique while advancing the plunger in the preloaded system.If the plunger is pushed too forcefully, or if the lens is not properly aligned, it may cause stress on the haptic, leading to breakage.-inadequate ovd application: insufficient or uneven application of the ophthalmic viscosurgical device (ovd) may have increased friction during the injection process, potentially causing the haptic to bend or break under the stress of insertion.-dwell time post-preparation: if there was a delay between lens preparation and implantation, the lubricity of the ovd could have decreased, increasing the risk of mechanical stress during injection, which could have contributed to the damage.-without the return of the broken lens for evaluation, the exact root cause cannot be definitively determined.However, improper handling during the implantation process or variability in technique is considered a likely contributing factor.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.

• 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: 20351409
• Report Number: 3010126268-2024-00091
• Device Sequence Number: 18148828
• Product Code: HQL
• UDI-Device Identifier: 00843045102359
• UDI-Public: (01)00843045102359(11)230406(17)260331
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/02/2024

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: 03/31/2026
• Device Model Number: 621P
• Device Catalogue Number: 003500-0056-489
• Device Lot Number: 3S230397
• 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: 09/20/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2023
• 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