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

Model Number	602
Medical Device Problem Codes	Optical Decentration (1360); Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been returned to the manufacturer.Therefore, a proper root cause analysis could not be completed, nor the reported issue confirmed.Without a proper device analysis, a definitive root cause cannot be determined at this time.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.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.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.
Event or Problem Description
It was reported that there was a subluxation of the lens.Original surgery (implantation) was on (b)(6) 2024.The next day, the patient complained of visual disturbance.Lens explanted and replaced with another ct lucia 602 with power 18.0 the next day (b)(6) 2024.
Additional Manufacturer Narrative
Field d9: updated to "yes".Field g3: updated "date received by manufacturer." field g6: updated to "follow-up # 1 and 30-day".Field h2: select "additional information and device evaluation".Field h3: updated to "yes".Field h6: added "component code" 4720.Added "type of investigation" code 10.Attach the evaluation summary - evaluation summary (3010126268-2024-00041).

• 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: 19018695
• Report Number: 3010126268-2024-00041
• Device Sequence Number: 8172951
• Product Code: HQL
• UDI-Device Identifier: 00843045100898
• UDI-Public: (01)00843045100898(17)270930
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: 003500-0050-668
• Device Lot Number: 3S220930
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2022
• 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