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

Model Number	CNWTT3
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Blurred Vision (2137)
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non-healthcare professional reported after one to two weeks of cataract and intraocular lens (iol) implant procedure, the patient experienced small spots and blurred vision in both eyes and was hospitalized.No inflammation was observed, and the surgeon suspected that the cause may be related to the lens or the viscoelastic.The patient¿s current condition was not reported.The surgeon reported that the cold chain was probably no longer in optimal condition and it was not possible to detect the problem before using the product, and the procedure was completed on the same day without delay.There were two medical device reports associated with this patient, and this report was associated with the right eye.Additional information was requested but was not available at the time of this report.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC 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: 25810528
• Report Number: 9612169-2026-01603
• Device Sequence Number: 10733736
• Product Code: MJP
• UDI-Device Identifier: 00380652468763
• UDI-Public: (01)00380652468763(17)270114(11)230116(10)25567424
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2026

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: CNWTT3
• Device Catalogue Number: CNWTT3.330
• Device Lot Number: 25567424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 07/14/2026
• Date Device Manufactured: 01/16/2023
• 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: CENTURION, ACCESSORY, HANDPIECE.; DISCOVISC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female