MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON TORIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNW0T6
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that after an intraocular lens (iol) implant procedure, the lens issue unspecified and explant.Additional information has been requested.

• Brand Name: CLAREON TORIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23888472
• Report Number: 9612169-2025-02580
• Device Sequence Number: 4771134
• Product Code: MJP
• UDI-Device Identifier: 00380652411202
• UDI-Public: (01)00380652411202(17)270614(11)230616(10)25660867
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/24/2025

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: CNW0T6
• Device Lot Number: 25660867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/24/2025
• Date Device Manufactured: 06/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CARTRIDGE TYPE; UNKNOWN INJECTOR/HANDPIECE; UNKNOWN VISCOELASTIC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male