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	11/12/2024
Type of Reportable Event	Malfunction
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 an intraocular lens (iol) implant procedure, the patient experienced glistening and visual problems two years after the surgery.Additional information has been requested.There are two medical device reports associated with this patient.This file is for left eye (os).
Additional Manufacturer Narrative
Additional information was provided in b.5.And d.10.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating that patient complains about quality of vision and everything was foggy.The idea of removing the lenses was not being considered due to the risk involved.
Additional Manufacturer Narrative
Additional information was provided in a.1., b.6., d.6.A., h.3., h.6.And h.11.The product was not returned.Photo evaluation provided by global quality customer affairs (gqca): three images were provided and reviewed associated with a report of visual problems associated with glistenings.The first two images show possible areas of diffuse refractile bodies where it is difficult to determine the location or more information based on the appearance.The third image appears to demonstrate a more characteristic appearance of discreet refractile bodies within the bulk of the intraocular lens (iol) which could be consistent with microvacuoles associated with glistenings.Ocular factors outside of glistenings can be an additional consideration for possible association with decreases in vision.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 of visual issues.The lens remains implanted.Photos were provided which showed possible areas of diffuse refractile bodies where it was difficult to determine the location or more information based on the appearance.One image appeared to demonstrate a more characteristic appearance of discreet refractile bodies within the bulk of the iol, which could be consistent with microvacuoles associated with glistenings.Ocular factors outside of glistenings can be an additional consideration for possible association with decreases in vision.Information was provided that there are no plans to explant the lens at this time.The file will be reopened if new information becomes available.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20914657
• Report Number: 1119421-2024-02462
• Device Sequence Number: 15603269
• Product Code: MFK
• UDI-Device Identifier: 00380652357906
• UDI-Public: (01)00380652357906(17)240229(11)190319(10)12697218
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2025

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: 02/29/2024
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.285
• Device Lot Number: 12697218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 12/17/2024; 01/10/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/09/2025; 02/04/2025
• Date Device Manufactured: 03/19/2019
• 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: CLAREON MONARCH IV INJECTOR; MONARCH III CARTRIDGE D; UNKNOWN VISCOELASTIC
• Patient Sex: Unknown