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

Model Number	CNWTT3
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Corneal Edema (1791); Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Pain (4467); Eye Irritation (4803); Posterior Capsule Opacification (4807)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
A non-healthcare professional reported that after surgery, on day one post-operation, the patient had mild corneal edema, painful yesterday, and irritation much better today, just a little irritated and blurry vision.The patient used topical corticosteroid, antibiotic, and nonsteroidal anti-inflammatory drug (nsaid) and stopped the ocular hyperosmotic agent.In the follow-up visit, the patient was 2 ½ weeks post-operation, vision was still blurry, right eye (od) not good either, but there was no pain, no pressure, using med drops well.The lens had rotated 120 degrees and needed repositioning of the lens and diagnosed with mild posterior capsule opacification (pco).After 4 ½ weeks visit, quality was unchanging.But the left eye is progressing as good as od, seen flashes of light in the periphery off/on lights are still bothersome all day ou (both eyes), denies pain/discomfort by taking corticosteroid.The patient already had dry eye syndrome of bilateral lacrimal glands secondary to tear deficiencies, so the patient¿s eyes are dry and irritated, so they continued tears and steroids as prescribed.After 6 ½ weeks visit, the patient was very light-sensitive, so has to wear sunglasses inside the house, eyes were really hurting, burning, and tearing excessively, had drops.Still seeing reflections of light and dryness in ou.In follow-up before repositioning of lens in the left eye for over the last week, quality was improving from her last examination by using steroids and had allergies.The patient was dissatisfied with the lens due to halos around lights at night.The lens has rotated from 120 to 125 degrees, started with steroids again.After 3 months, the last visit was 5 weeks ago.Quality was unchanging.Severity is described as moderate.The patient described that vision was not good in os and dissatisfied because she cannot drive at night either eye.Steroid has been out for about 10 days.So, the multifocal lens was exchanged with another monofocal lens in a secondary implant procedure.There are two medical reports associated with this patient.This file belongs to left eye.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21354659
• Report Number: 1119421-2025-00350
• Device Sequence Number: 7741071
• Product Code: MJP
• UDI-Device Identifier: 00380652468541
• UDI-Public: (01)00380652468541(17)280512(11)240514(10)15855689
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.205
• Device Lot Number: 15855689
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 02/11/2025
• Date Device Manufactured: 05/14/2024
• 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: 0.27 GAUGE CANNULA.; 1% XYLOCAINE PF.; 2.4 MM KERATOME.; ARTIFICIAL TEARS.; ATORVASTATIN 10 MG.; BESIVANCE 0.6%.; BSS (BASE SALT SOLUTION).; CYSTOTOME NEEDLE.; ESTRADIOL 0.01%.; FINASTERIDE.; INVELTYS.; KETOROLAC 0.5%.; MOXIFLOXACIN.; MURO.; MYD + NEO.; MYRBETRIQ 25 MG.; PRED FORTE 1%.; PREDNISOLONE ACETATE 1%.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.; SIMBRINZA.; SUPERSHARP BLADE.; SYSTANE.; TOBRAMYCIN 0.3-0.1 %.; UNSPECIFIED IOL ROTATER, OINTMENT, DROPS.; UTRATA FORCEPS.; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Female