MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFNT00
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.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 healthcare professional reported that following an intraocular lens implantation procedure the patient had reduced vision due to glistenings.There was a planned explant.Additional information has been requested.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
Additional information was provided in a.1., a.2., a.3.A., b.5., b.6., b.3., d.1., d.2., d.3., d.4., d.6.A., d.10.,h.3., h.6.And h.11.The product was not returned.Complaint and product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.Each lens is subjected to a 100percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the vision in the right eye (b)(4), which has had a yag capsulotomy has improved to 0.0 logmar unaided for distance and n5 unaided for near following a lasik enhancement procedure in january.As a result, surgeon is not considering explanting the lens from the left eye (which has not yet had a yag capsulotomy).The glistenings look symmetrical and now that the refraction has been optimized in the right eye the patient is happy with the vision in that eye.The surgeon indicated that it would be safer to optimize the left eye with a yag capsulotomy plus or minus lasik rather than explant the lens.File will be reopened if new information is received related to the treatment for the left.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 has been received and stated that the vision in the right eye (which has had a yag capsulotomy) has improved to 0.0 logmar unaided for distance and n5 unaided for near following a lasik enhancement procedure in january.As a result, the surgeon reluctant to explant the lens from the left eye (which has not yet had a yag capsulotomy).The glistening look symmetrical and now that the refraction has been optimized in the right eye the patient is happy with the vision in that eye.
Additional Manufacturer Narrative
Corrected information provided in h.6.And h.11.Correction: on initial mdr the evaluation code of b17 was an error.It should have been b20 on the original mdr.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.

• Brand Name: ACRYSOF IQ PANOPTIX TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• 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: 21332072
• Report Number: 1119421-2025-00320
• Device Sequence Number: 20790298
• Product Code: MFK
• UDI-Device Identifier: 00380652357746
• UDI-Public: (01)00380652357746(17)230831(11)180920(10)12652970
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.205
• Device Lot Number: 12652970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 03/25/2025; 04/28/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/22/2025; 05/21/2025
• Date Device Manufactured: 09/20/2018
• 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: HEALON OVD.; MONARCH II IOL, INJECTOR.; MONARCH IOL, CARTRIDGE.
• Patient Age: 57 YR
• Patient Sex: Male