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	09/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation revealed that the ct lucia 602 lens was implanted using the yamane technique, which is an off-label use for this product.The yamane technique involves a unique scleral fixation of the intraocular lens, which can present challenges not typically encountered with standard implantation methods.This off-label use can contribute to complication's such as difficulty centering the lens or haptic deformation.Given that the lens is not designed or labeled for use with the yamane technique, this deviation from the intended use may have caused the observed issue of both haptics being bent and the lens appearing rotated in the eye.The iol is intended for standard implantation techniques, and the use of the yamane technique may result in increased mechanical stress on the lens haptics, causing the abnormal positioning noted by the surgeon.No manufacturing deviations or product non-conformities were found during the review of the manufacturing records.Therefore, it can be concluded that the root cause of this issue is related to the off-label use of the product rather than a product defect or quality issue.
Event or Problem Description
It was reported that the ct lucia lens was implanted using the yamane technique.The surgeon noticed that the lens tilted and appears to have rotated about the optic haptic junction.The lens was explanted in an additional surgery on the same day.Patient was left aphakic and surgeon plans to implant a replacement lens at a later date.
Additional Manufacturer Narrative
Description of changes: field b4: added "date of this report" 10/31/2024.Field b5: updated, "describe event or problem".Field g3: updated "date received by manufacturer" to "10/22/2024".Field g6: checked "30 days", updated to "follow-up, # 1".Field h2: follow-up, what type?, checked "additional information".Field h11: added description of changes.
Event or Problem Description
After implantation with yamane technique, the lens tilted and appeared to have rotated about the optic haptic junction.The lens was explanted in an additional surgery on the same day.The lens exchange surgery was successfully done on (b)(6) 2024.The surgery went well and the patient was discharged the same day.

• 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: 20403560
• Report Number: 3010126268-2024-00092
• Device Sequence Number: 6479702
• Product Code: HQL
• UDI-Device Identifier: 00843045100959
• UDI-Public: (01)00843045100959(17)280229
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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: 003500-0050-674
• Device Lot Number: 3S230335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown