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

Model Number	602
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: investigation findings preferred term: incompatible lens size; investigation conclusions preferred term: incompatible lens size.Reviewing the manufacturing documents did not show any indications for a malfunction of the iol.As per documentation the product was produced in accordance with manufacturer's specification and no deviation has been detected.Based on our experience with similar cases that are already resolved, we can assume that the lens' size didn't fit with the sizing of the patient's eye.The phenomenon of post-op iol rotation happens mainly with highly myopic patients, who usually (but not necessarily) have a large capsular bag and long axial length and because the iol is kind of floating in the bag until the bag shrinkage stabilizes the lens' position.As soon as the capsular bag starts to shrink, the lens gets stabilized in the eye and can be re-rotated to the final position.The time can vary from patient to patient and surgeons usually perform re-rotation after about 2 weeks.If it´s done too early, the lens might be not stabilized yet and can rotate again.If the surgeon waits too long, the capsular shrinkage could make re-rotation more challenging and riskier.This kind of incident is not caused by the product or iol design.Rotation of the iol is probably caused by the size or shape of the patient's capsular bag, surgery technique or left ovd behind the iol.Rotation can also occur with any other iol types, e.G.C-loop shaped haptics, for these large bags.
Event or Problem Description
The surgeon stated that the lens was malrotated in the eye and had to be cut out and couldn't be saved.The patient had to have another surgery to remove the malrotated lens and replace it with aciol.

• 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: manjaya hegde ; 5300 central parkway; dublin, CA 94568
• MDR Report Key: 24254910
• Report Number: 3010126268-2026-00003
• Device Sequence Number: 18229302
• Product Code: HQL
• UDI-Device Identifier: 00843045100805
• UDI-Public: (01)00843045100805(17)300131
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100016 S022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 02/03/2026

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: 003500-0050-659
• Device Lot Number: 3S250104
• 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: 01/08/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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