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

Model Number	CNWTT6
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
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.Provided photo shows a close-up image of an eye.There are blue light illuminations over the eye.There are whitish marks visible over the centre of the eye.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that after intraocular implantation surgery surgeon has noticed whitish/opaced lens slightly off center of the lens optic on day one of post op.No patient harm was reported.
Additional Manufacturer Narrative
The product was not returned for analysis.Only photos were returned.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Eight images are provided in one photograph.One image is displayed in a larger format and the remaining seven appear as small thumbnail images.The thumbnails are not large enough to permit adequate assessment.The larger image shows an approximately two to three millimeter vertically oriented slit beam directed from left to right.Within this illumination, a mottled reflective and or white-colored finding is partially visible behind the periphery of a miotic pupil at approximately the two to four o¿clock position.When evaluated objectively, the available image does not provide sufficient detail to determine the position or status of the posterior chamber intraocular lens or to determine whether the white finding is located on the anterior surface, within the optic, or on the posterior surface of the lens.Subjective interpretation would require speculation, which would introduce interpretive influence beyond what the image supports.Based on the photograph alone, the finding cannot be conclusively identified.Additional information is required to characterize the finding and assess its relevance to the associated complaint investigation.The root cause for the reported complaint could not be determined.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 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: 23850530
• Report Number: 9612169-2025-02551
• Device Sequence Number: 9526958
• Product Code: MJP
• UDI-Device Identifier: 00380652470056
• UDI-Public: (01)00380652470056(17)260817(11)220819(10)25460018
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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 Expiration Date: 08/17/2026
• Device Model Number: CNWTT6
• Device Catalogue Number: CNWTT6.165
• Device Lot Number: 25460018
• 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: 11/23/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/20/2026
• Date Device Manufactured: 08/19/2022
• 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: ALBOMED PE-HA-LURON F 1.0%; CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Sex: Unknown