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	11/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Based on the information provided, the risk assessment for the ct lucia 3-piece product, and our experience, we have determined that the following factors may have caused or contributed to the reported issue: improper handling or off-label surgical technique: the breaking of the haptic may have been caused by improper handling during the lens loading process or during preparation for implantation.It is noted that the yamane technique was employed in this case, which is an off-label use for this lens.The ct lucia 3-piece lens is not designed or recommended for use with the yamane technique, as this method subjects the haptics to increased stress and risk of deformation, making it unsuitable for such off-label applications.If the haptic is not aligned properly within the injector or if excessive force is applied during loading, it could result in bending or breaking of the haptics that then results in rotation of the optic.
Event or Problem Description
A customer reported the ct lucia 602 lens to be "damaged and explanted" after use of the yamane technique.No patient harm was reported.

• 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 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: 20904918
• Report Number: 3010126268-2024-00105
• Device Sequence Number: 9207194
• Product Code: HQL
• UDI-Device Identifier: 00843045100935
• UDI-Public: (01)00843045100935(17)281031
• Combination Product (Y/N): N
• 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): 12/11/2024

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: 003500-0050-672
• Device Lot Number: 3S231792
• 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: 11/14/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2023
• 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