MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC CT LUCIA; CT LUCIA 602

Model Number	602
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the haptic broke after implantation.The lens had to be explanted and replaced by a back-up lens.
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 device is on its way to manufacturer therefore a proper root cause analysis could not be completed yet nor the reported issue confirmed.Without a proper device analysis, a definitive root cause cannot be determined at this time.There was no damage reported to have been noticed during the inspection prior to use and preparation, which suggests a product deficiency, did not contribute to the reported difficulties.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; · poor handling during folding and inserting.
Additional Manufacturer Narrative
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 within the technical file for the three-piece hydrophobic lens.The risk assessment identifies failed injection/damaged haptics to potentially be caused by the lens beingimproperly loaded such that the optic is bent or haptics are under compression.This is seen as a reasonably foreseeable misuse that may result is an extended surgery because of the damage to the lens/injector and a replacement is required.This is a considered a minor severity of damage.The likelihood of occurrence is estimated to be occasional.The resulting risk is deemed as acceptable.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: 19111628
• Report Number: 3010126268-2024-00048
• Device Sequence Number: 20611087
• Product Code: HQL
• UDI-Device Identifier: 00843045100935
• UDI-Public: (01)00843045100935(17)271031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 003500-0050-672
• Device Lot Number: 3S221083
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• 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