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 Codes	Visual Impairment (2138); Swelling/ Edema (4577)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While the ct lucia 602 lenses are known for their rotational stability, certain anatomical or surgical factors can lead to instability.Factors such as improper alignment during insertion, insufficient or excessive ovd use, or variability in patient anatomy (e.G., a larger or more elastic capsular bag) could contribute to lens spinning.Surgical technique: the spinning of the lens could be related to the technique used during implantation.If improper technique or insufficient fixation of the haptics was employed, this could lead to lens movement.Patient-specific factors: the size and elasticity of the patient's capsular bag could also affect how well the lens remains stable after implantation.If the capsular bag is too large or lax, the iol may not stay in the intended position, leading to spinning.This is especially relevant for patients who may have had previous surgeries, larger-than-average eyes, or unique anatomical considerations.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 the lens was "spinning" in the eye.The lens was explanted and replaced with another lens during the same surgery.

• 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 manjaya ; 5300 central parkway; dublin, CA 94568 ; 9255574259
• MDR Report Key: 20464684
• Report Number: 3010126268-2024-00093
• Device Sequence Number: 18113064
• Product Code: HQL
• UDI-Device Identifier: 00843045100959
• UDI-Public: (01)00843045100959(17)260228
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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 Expiration Date: 02/28/2026
• Device Model Number: 602
• Device Catalogue Number: 003500-0050-674
• Device Lot Number: 3S210318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown