MAUDE Adverse Event Report: Carl Zeiss Meditec Production LLC CT LUCIA; Intraocular Lens ( IOL)

Model Number	621 P
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	09/10/2026
Type of Reportable Event	Serious Injury

• Brand Name: CT LUCIA
• Common Device Name: Intraocular Lens ( IOL)
• 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 ; +1(925)557-4259
• MDR Report Key: 50892363
• Report Number: 3010126268-2026-00044
• Device Sequence Number: 10706022
• Product Code: HQL
• UDI-Device Identifier: 00843045102427
• UDI-Public: (01)00843045102427(11)250919(17)280831
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P100016 S027
• 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): 09/24/2026

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: 621 P
• Device Catalogue Number: 003500-0056-496
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2025
• 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