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

Model Number	CCWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Blurred Vision (2137); Posterior Capsule Opacification (4807)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that following cataract surgery with an intraocular lens (iol) implant procedure, there was dense posterior capsular opacification, grade 2 anterior capsule fibrosis and lens rotation at five weeks post operation.Additional information requested and received stating that grade 1 pco and grade 2 acf at seven weeks post operation.Patient was prescribed ophthalmic eye drop as postoperative medication containing combination of corticosteroid, broad-spectrum antibiotic and non-steroidal anti-inflammatory drug.Yag (yttrium aluminum garnet) laser capsulotomy performed.In the surgeon¿s opinion the product contributes to the event.
Additional Manufacturer Narrative
This report originally filed as 9612169-2025-00561 mfg site cork ireland.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).
Additional Manufacturer Narrative
Corrected information was provided in h.6.On initial mdr submitted the evaluation method code should be b20 instead of b17.Additional information was provided in h.3.And h.11.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 posterior capsular opacification (pco), anterior capsule fibrosis (aco), phimosis, and intraocular lens (iol) rotation off-axis with company lenses, an 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 TRIFOCAL UV ABSORBING INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 22024564
• Report Number: 1119421-2025-01400
• Device Sequence Number: 7220453
• Product Code: MFK
• UDI-Device Identifier: 00380652413688
• UDI-Public: (01)00380652413688(17)260619(11)220621(10)15437142
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2026
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.220
• Device Lot Number: 15437142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/07/2025
• Date Device Manufactured: 06/21/2022
• 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 DELIVERY SYSTEM, INJECTOR.; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female