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

Model Number	CNW0T4
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 physician reported that following an cataract surgery with intraocular lens (iol) implant procedure, the surgery was performed on (b)(6) 2025 and was completed without any issues, but during the morning rounds on (b)(6) 2025 a problem was observed where the optical surface of the iol appeared to have had a film of oil.Upon examination, there were no differences between the eyes and vision was good, so there did not seem to be any adverse health effects.The situation was being monitored.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo was returned.The reported complaint was observed on the returned photo.Provided photo shows a close-up image of an eye.There appears to be cloudiness/light reflections over the iol (intraocular lens).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.The cause of ¿sheen¿ or ¿film-like¿ appearance is a result of a change in the positioning of the iol during the manufacturing process and is not associated with any foreign material or contamination.The observation has been reported clinically and confirmed in laboratory settings to disappear over time following implantation.The appearance is a result of a temporary change in the surface of the iol that occurs during the delivery process, which is only visible under certain orientations and illumination settings.This resolves once the iol is delivered and exposed to body temperature over time.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 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).

• 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: 23787172
• Report Number: 9612169-2025-02482
• Device Sequence Number: 17529395
• Product Code: MJP
• UDI-Device Identifier: 00380652410212
• UDI-Public: (01)00380652410212(17)280324(11)240326(10)25819773
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: CNW0T4
• Device Lot Number: 25819773
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/19/2026
• Date Device Manufactured: 03/26/2024
• 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: BOSMIN; OVD: HEALON/HEALONV
• Patient Sex: Unknown