MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CNWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	12/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, he lost clear vision in dim light, was seeing halos and glare, unable to drive at night, vision got blurry while watching the television.While watching the tv patient felt like the footnotes are coming close to eyes and are blur.Also stated he had a consultation with ophthalmologist and was prescribed 0.5 number single vision lens which has helped him 30%.Additional information was received stating that he did not have vision clarity and had blurry vision.Additional information was received stating, surgeons feedback was that the patient came to clinic demanding current model company lens as he surveyed from different hospitals.After implanting, post operative were good.After 15 days follow up, patient was complaining about slight glares at night, but the surgeon counselled him and told him these are few draw backs of all trifocals.The patient did not come back after 15 days follow up.There are two medical device reports associated with this patient.This file is for left eye.
Additional Manufacturer Narrative
Additional information was provided in a.1., a.2.,b.5., b.6., b.7.,d.4.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
Additional information was received stating, as per surgeon the patient enquired about company lens previously at multiple clinics before getting operated and demanded to be operated with the company lens.After implantation he came only once for follow-up and as per surgeon his vision was 6/6 distance and n6 near.Surgeon also mentioned that patient was a pharma medical representative and was informed about the halos and glares before getting operated.The left eye was implanted with 21 diopter company lens.

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21592538
• Report Number: 9612169-2025-00370
• Device Sequence Number: 15673018
• Product Code: MFK
• UDI-Device Identifier: 00380652408141
• UDI-Public: (01)00380652408141(17)270212(11)230214(10)25586619
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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 Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.210
• Device Lot Number: 25586619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 08/05/2025
• Date Device Manufactured: 02/14/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male