MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWTT3
Medical Device Problem Codes	Particulates (1451); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Posterior Capsule Opacification (4807)
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, patient experienced with posterior capsule opacification (pco) and the iol was rotated.A grade 2 pco was identified after 3 months post-operative.Additional information has been received and stated that stated that the grade 2 pco at 3 months, iol was rotated axis from 12 degrees to 30 degrees, concerned regarding the lens material verses cartridge material causing the lens to be slick and rotate.The surgeon noticed cartridge material adheres to posterior surface of les requiring removal with irrigation and aspiration but that can sometimes be difficult.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
This report originally filed as 9612169-2025-00584.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
Postop visit intervals the patient experienced floaters.
Additional Manufacturer Narrative
Correction information was provided in b.5., h.6., and h.11.Additional information was provided in h.3., h.6.And h.11.Correction: on initial mdr the fda patient code of e083803 was missed.It should have been submitted in the initial mdr.In the initial mdr, the product code a030205 was entered in error and is no longer required in the original mdr.The product was not 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.Qualified associated products were indicated.The root cause for the reported events could not be determined.The lens remains implanted.Regarding the findings of pco, aco, phimosis, and iol rotation off axis with company lenses, a company director of global technical customer affairs consulted with the surgeon and provided information related to the reported events.Because these findings are related to clinical outcomes, review of complaints for the reported event types is the primary investigation focus to assess for potential concerns related to anterior/posterior capsule opacification, phimosis, and lens rotation.Information was also provided that because clinical outcomes are complex with numerous potentially associated clinical and surgical factors, additional information could be discussed with the account representative, including options such as a peer to peer communication service called expert opinion md, that company offers at no charge.Reports of these event types have remained low and stable, with intermittent reporting as expected, based on the potential multifactorial etiology.An additional global review was conducted to look at the reported incidence for each of the above outcomes over the past 3 years.All global complaints are evaluated monthly for adverse trending, and no adverse trends were identified for these events.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22077187
• Report Number: 1119421-2025-01468
• Device Sequence Number: 13102198
• Product Code: MJP
• UDI-Device Identifier: 00380652457347
• UDI-Public: (01)00380652457347(17)260718(11)220720(10)15450253
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.180
• Device Lot Number: 15450253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/26/2025
• Date Device Manufactured: 07/20/2022
• 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: CLAREON MONARCH IV IOL , INJECTOR; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH II LOADING FORCEPS; MONARCH III IOL , CARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female