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	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	08/20/2024
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 health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision and glare.The iol was explanted and exchanged with unspecified lens of different model in the secondary implant procedure.The patient's events were recovered.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The lens was returned taped to a small piece of white paper and sealed inside a self sealing pouch.Viscoelastic was observed on the lens.The lens was cleaned with klrp to remove the dried viscoelastic and adhesive from the tape in order to further evaluate.One haptic posterior surface distal edge had a broken area with a scratch mark.No other lens damage was observed.A power and resolution test was conducted by an engineering tech.The lens met specification for a company lens 23.0 diopter (add power +2.2/+3.2 diopter).Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were used.The root cause cannot be determined for the reported complaint of "blurred vision and glare (explant)¿.Each lens is 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.A power and resolution retest was conducted.The lens met specification for a company lens 23.0 diopter (add power +2.2/+3.2 diopter).The company lens 23.0 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non-comapny monofocal 23.0 diopter.Due to the exchange of a multifocal lens to a monofocal lens, this may suggest that a monofocal lens was an improved selection for this patient's vision needs.File will be reopened if new information is received.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: 22371141
• Report Number: 1119421-2025-01792
• Device Sequence Number: 7952908
• Product Code: MFK
• UDI-Device Identifier: 00380652413701
• UDI-Public: (01)00380652413701(17)260410(11)220412(10)15392949
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 08/14/2025

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: 04/10/2026
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.230
• Device Lot Number: 15392949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/14/2025
• Date Device Manufactured: 04/12/2022
• 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: DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; UNSPECIFIED FORCEPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female