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

Model Number	003500-0050-676
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the doctor was using the yamane scleral fixation technique to implant a ct lucia 602, the case went without any issue.However, on post-op, the optic had tilted.The doctor had to take the patient back to or to explant iol.New iol was implanted successfully without any issues.No additional information provided.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).Article cite: initial safety profile assessment of the navio robotic-assisted total knee arthroplasty, international society for technology in arthroplasty (ista) meeting, 32nd annual congress, toronto, canada, october 2019.

• Brand Name: CT LUCIA 602
• 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: charlie ortiz ; 1040 s vintage ave. bld. a; ontario, CA 91761 ; 9099065165
• MDR Report Key: 15251133
• Report Number: 3010126268-2022-00016
• Device Sequence Number: 5847778
• Product Code: HQL
• UDI-Device Identifier: 00843045100973
• UDI-Public: (01)00843045100973(17)260430
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2022

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: 04/30/2026
• Device Model Number: 003500-0050-676
• Device Catalogue Number: 003500-0050-676
• Device Lot Number: 3S210533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2021
• 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