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	07/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned lens exhibits clear evidence of excess stress being induced on the lens.This force can be caused by friction, which can be caused from several factors including but not limited to; improperly applied ovd, excessive injection speed, or improperly placed iol.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.The dhr indicates that the lenses were processed per standard operating procedures and met all final release specifications.A query of complaint-handling database revealed no indication of a lot specific product quality deficiency.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.
Event or Problem Description
The surgeon implanted the lens using the yamane technique then explanted the lens during the same surgery due to the lens being cracked.The patient was left aphakic.Three good faith attempts were made to discover if replacement lens is to be implanted, but customer has not responded.

• 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: 20040882
• Report Number: 3010126268-2024-00084
• Device Sequence Number: 18153688
• Product Code: HQL
• UDI-Device Identifier: 00843045101031
• UDI-Public: (01)00843045101031(17)281231
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/21/2024

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: 003500-0050-682
• Device Lot Number: 3S240024
• 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: 07/25/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown