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	09/04/2024
Type of Reportable Event	Serious Injury
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.Based on the information provided and our experience with the lucia product, we have determined that the following factors may have contributed to the reported issue of kinked haptics during loading: improper handling or loading error: the scrub tech's improper loading technique is likely the main contributing factor.If the lens was not correctly aligned within the cartridge or if excessive force was applied during the loading process, this could have caused the haptics to become kinked.Use of the yamane technique: the yamane technique, which places increased stress on the haptics due to the method of fixation, may have further contributed to the kinking, especially if the loading process was already compromised.The yamane technique is off label use.Lack of lens availability for evaluation: since the lens was discarded, a definitive root cause cannot be established.However, the most probable contributing factors are identified based on the available information and previous experiences with similar cases.Without the device for evaluation, the exact root cause cannot be conclusively determined, but the factors listed above are considered the most likely contributors to this complaint.
Event or Problem Description
Customer reported that haptics were damaged as a result of improper loading into the cartridge by a scrub technician.There was no patient harm.The lens was partially inserted into the sulcus using the yamane technique.The lens was removed and replaced with a spare lens.The lens was discarded.

• 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: 20326165
• Report Number: 3010126268-2024-00088
• Device Sequence Number: 7783393
• Product Code: HQL
• UDI-Device Identifier: 00843045100881
• UDI-Public: (01)00843045100881(17)260731
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/27/2024

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: 07/31/2026
• Device Model Number: 602
• Device Catalogue Number: 003500-0050-667
• Device Lot Number: 3S210940
• 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: 09/05/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2021
• 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