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	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer implanted the ct lucia 602 lens on (b)(6) 2023.It was reported that the superior haptic was not fully embedded.There was a gap from the end of the haptic to where it should be embedded within the optic.Due to an improperly staked haptic, the iol was able to rotate.It took multiple attempts to reposition the iol, and added nearly an hour to the procedure.This iol was explanted on (b)(6) 2023, and a backup zeiss lens was implanted the same day without complication.
Additional Manufacturer Narrative
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 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-conformance's 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.

• 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: 18043851
• Report Number: 3010126268-2023-00115
• Device Sequence Number: 15320650
• Product Code: HQL
• UDI-Device Identifier: 00843045100928
• UDI-Public: (01)00843045100928(17)260831
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 10/31/2023

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: 08/31/2026
• Device Model Number: 602
• Device Catalogue Number: 003500-0050-671
• 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: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• 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