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

Model Number	CNWET3
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.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 physician reported that following an intraocular lens (iol) implant procedure, the surgeon had noticed sub surface nano glistenings (ssngs).In the surgeon¿s opinion, the product did cause or contribute to the event.The patient had no harm and visually asymptomatic.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photos were returned.The reported complaint was observed on the returned photos.Provided photos show an implanted iol.Polychromatic sheen can be observed on the iol.The root cause is deemed to be manufacturing related.Complaints have been received describing that lenses were reported by doctors for the presence of a ¿polychromatic sheen¿ visible.This observation has been reported clinically and confirmed in laboratory settings to disappear over time following implantation and is often no longer visible by one day following surgery.However, in some cases, this observation may be apparent for longer before disappearing.The appearance is a result of a temporary change in the surface of the iol that occurs during the delivery process and is not associated with any foreign material or contamination.This is only visible under certain orientations and illumination settings and begins to resolve over time once the iol is delivered.The cause of the appearance is a result of a change in the positioning of the iol that was implemented in the manufacturing process and has since been addressed in production.There are no adverse impacts or lasting effects on the iol or the patient.Based on the results of the product investigation and testing, it was confirmed that there are no adverse events or clinical impact on vision associated with this finding.Based on the results from the product history record, the products met release criteria.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.

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION 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: 24815717
• Report Number: 9612169-2026-00787
• Device Sequence Number: 12264893
• Product Code: MJP
• UDI-Device Identifier: 00380652466424
• UDI-Public: (01)00380652466424(17)270228(11)230302(10)25602208
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWET3
• Device Lot Number: 25602208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2026
• Supplement Date Received by Manufacturer: 04/16/2026; 06/09/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/08/2026; 07/01/2026
• Date Device Manufactured: 03/02/2023
• 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: MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 84 YR
• Patient Sex: Male