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	10/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 based on our experience, we have determined that the following factors may have caused or contributed to the reported issue, but are not limited to: · lens placement technique · loading strategy · accessory device support · poor handling during folding and inserting a review of the device history records did not reveal any non-conformances that would have contributed to the reported event.The dhr review 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.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.
Event or Problem Description
The customer reported that the haptic disinserted during a lens implantation surgery with a 20g yamane technique on (b)(6) 2023.The lens was explanted.

• 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: 18035829
• Report Number: 3010126268-2023-00114
• Device Sequence Number: 17997025
• Product Code: HQL
• UDI-Device Identifier: 00843045100898
• UDI-Public: (01)00843045100898(17)260630
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P10016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/30/2023

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: 06/30/2026
• Device Model Number: 602
• Device Catalogue Number: 003500-0050-668
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• 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