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	Inflammation (1932); Posterior Capsule Opacification (4807)
Date of Event	03/15/2025
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 healthcare professional reported that following cataract surgery with an intraocular lens (iol) implant procedure, suspected toxic anterior segment syndrome (tass) was found after an iol was inserted.On (b)(6) 2025 at the hospital appointment, the right anterior chamber inflammation and formation of fibrin at the back side of the iol were confirmed.However, neither hypopyon nor vitreous inflammation were observed.The patient did not have any pain, and inflammatory cells are not so big.So, since these were not the findings to suspect bacterial endophthalmitis positively, postoperative inflammation or tass were suspected.The patient treated with steroid eye drops frequently and examined every day at the hospital.In the morning on (b)(6), the anterior chamber inflammation almost disappeared.From the progress, it is not identified whether a strong postoperative inflammation or tass.The patient's condition will improve getting conservative medical treatment.The current prescription included antibiotic, steroid and anti-inflammatory medication.
Event or Problem Description
Additional information received stating that fibrin was observed on postoperative day 3.Non-infectious postoperative inflammation and tass was diagnosis.There was no iol issue and no pain.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.11.The product was not returned for analysis.The root cause for the reported complaint could not be determined.The sterilization reports were reviewed and there were no issues with the sterilization process.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• 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: 21883200
• Report Number: 9612169-2025-00664
• Device Sequence Number: 18328399
• Product Code: MFK
• UDI-Device Identifier: 00380652408073
• UDI-Public: (01)00380652408073(17)260529(11)220531(10)25424158
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2025

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: 05/29/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.175
• Device Lot Number: 25424158
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 06/20/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/19/2025; 07/14/2025
• Date Device Manufactured: 05/31/2022
• 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: MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male