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	Foreign Body Sensation in Eye (1869); Headache (1880); Blurred Vision (2137); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 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 nurse reported that following intraocular lens (iol) implantation in the right eye, the patient experienced poor vision, described as film over the eye, along with headaches and a foreign body sensation.The lens was subsequently removed and replaced with an anterior chamber intraocular lens (atiol) in a secondary procedure.The clinical reason for explant was large myopic shift after implantation and mechanical complication of the iol.Based on additional information received on 03-feb-2026: the patient could not see well after original implantation procedure.The surgeon confirmed that the iol itself did not contribute to the events; instead, the refractive surprise was due to patient's prior refractive surgeries.The iol exchange was performed using the same model lens from the company, but with a lower power (six diopters less than the original).The patient's symptoms were resolved, and the surgeon reported a good prognosis.There was no further impact to the patient.
Additional Manufacturer Narrative
Additional information provided in sections d.9., h.3., h.6., and h.11.The lens was returned submerged in clear liquid inside a small, plastic specimen jar.Solution was dried on the lens.The optic was cut into two portions.One optic portion was scratched on the anterior surface near the edge.The power and resolution of the returned lens could not be re-evaluated due to the lens cut into pieces and the additional optic damage.A qualified cartridge and handpiece were indicated.A non-qualified viscoelastic was indicated.The root cause was determined to be unrelated to the lens.The completed questionnaire indicated that in the surgeon's opinion the complaint was unrelated to the lens.The reason was given as "the refractive surprise was due to prior refractive surgeries".The patient had previous lasik surgery.Each lens was subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.The company 22.5 diopter (add power +2.17/+3.25 diopter) lens was removed and replaced with a company 16.5 diopter (add power +2.17/+3.25 diopter) lens.This information of the replacement lens being the same lens model but 6 diopters less would also suggest and support that the diopter of the replacement lens was an improved selection for this patient's vision needs.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: 24408645
• Report Number: 1119421-2026-00373
• Device Sequence Number: 12837020
• Product Code: MFK
• UDI-Device Identifier: 00380652413695
• UDI-Public: (01)00380652413695(17)290422(11)250424(10)16030013
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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 Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.225
• Device Lot Number: 16030013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/21/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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: AMVISC; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; ORA SYSTEM WITH VERIFEYE MESSAGING; ORA SYSTEM WITH VERIFEYE MESSAGING, CART
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female