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

Model Number	CCWTT0
Medical Device Problem Codes	Particulates (1451); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Posterior Capsule Opacification (4807)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product was not returned for analysis.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).
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.The higher incidence of pco could be caused from the cartridges.Additional information has been requested.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
Correction information was provided in h.11.Correction: fda product problem code a051201 was removed.Additional information was provided in a.2.,a.3.A.,b.2.,b.3.,b.5.,b.6.,b.7.,d.1.,d.4.,d.6.A.,d.10.,e.4 and h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received and stated, patient experienced floaters at 6 weeks and grade 2 posterior capsule opacification (pco) at 3 months post-operative.It was also noticed that cartridge material adheres to posterior surface of lens requiring removal with irrigation and aspiration that can sometimes be difficult.Patient also had yttrium aluminum garnet (yag), lens and capsule polish procedures post-operatively.
Additional Manufacturer Narrative
Additional information was provided in h.6 and h.11.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 lens remains implanted.Regarding the findings of pco, aco, phimosis, and 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
• 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: 21843890
• Report Number: 1119421-2025-01032
• Device Sequence Number: 18168120
• Product Code: MFK
• UDI-Device Identifier: 00380652413633
• UDI-Public: (01)00380652413633(17)260216(11)220218(10)15346204
• 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,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2026
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.195
• Device Lot Number: 15346204
• 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: 03/17/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 06/13/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 05/21/2025; 07/07/2025
• Date Device Manufactured: 02/18/2022
• 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 IOLDELIVERY SYSTEM,INJECTOR; DUOVISC VISCOELASTIC SYSTEM; LIDOCAINE; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE; OPHTHALMIC BETADINE; PHENYLEPHRINE; PRED MOXI BROM OPHTHALMIC DROPS; TETRACAINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female