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	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported that a lens was implanted on (b)(6) 2024, but it was explanted immediately due to lens placement issues on their end.Another lens was implanted successfully.The yamane technique was used.
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.The returned device is on its way to the manufacturer.Therefore, a proper root cause analysis could not be completed, nor the reported issue confirmed.Without a proper device analysis, a definitive root cause cannot be determined at this time.It was stated by the customer that they are using the yamane technique to implant the lenses.This technique induces a larger amount of force while trying to position the haptics in the scleral tunnel.Our lenses are intended to be implanted in the capsular bag.Thus, the lens was being used off-label.Based on the information provided, the risk assessment for the lucia product, and our experience, we have determined that the following factors may have caused 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.
Additional Manufacturer Narrative
Section h6: added 10, testing of actual/suspected device.A review of the device history records did not reveal any non-conformances that would have contributed to the reported events.The dhr indicates that the lenses were processed per standard operating procedures and met all final release specifications.Additionally, a query of complaint-handling database revealed no indication of a lot specific product quality deficiency.However, there is no indication of a product quality issue with respect to manufacturing, design, or labelling.Our lenses are 100% thoroughly 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.The risk assessment has been reviewed for the three-piece hydrophobic lens.The risk assessment identifies failed injection or damaged haptics to potentially be caused by the lens being improperly loaded such that the optic is bent or that the haptics are under compression.This is seen as a reasonably foreseeable misuse that may result in an extended surgery because of the damage to the lens/injector and a replacement is required.The severity of damage is seen as minor.The likelihood of occurrence is estimated to be occasional.The resulting risk is deemed as acceptable.It was stated by the customer that there was no damage noted to the device during preparation for use.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 support device, poor handling during folding and inserting.

• 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: 19209495
• Report Number: 3010126268-2024-00053
• Device Sequence Number: 7927689
• Product Code: HQL
• UDI-Device Identifier: 00843045100850
• UDI-Public: (01)00843045100850(17)280131
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 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): 07/03/2024

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 Model Number: 602
• Device Catalogue Number: 003500-0050-664
• Device Lot Number: 3S230120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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