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

Model Number	TFNT50
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.Photos were provided.The photos were reviewed by global quality customer affairs (gqca).There are nine photos in total of what appears to be the same iol.The photos are of a dilated eye at medium or high magnification.The photos with the best lighting show an opaque iol, with consistent opacity throughout the lens.A red reflex is not present through the lens.The observed opacity is of unknown origin.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.No conclusion could be determined from the provided photos.Information provided indicated the patient has not made any complaints about their vision.The issue was noted by the surgeon.Surgeon will follow up with the patient in six months.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
An other medical professional stated that following surgery, a whitish lens was seen in the left eye during ophthalmological monitoring and doctor knows about nano glistening's and surface beam of the platform.The patient's eye is losing vision, but they are not complying.That eye was presumably the worst in the past, but the patient continues to see it rarely and doesn't notice it.So the doctor gave him a call for a follow-up exam in six months.Additional information has been requested.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 20210139
• Report Number: 1119421-2024-01805
• Device Sequence Number: 7327845
• Product Code: MFK
• UDI-Device Identifier: 00380652390965
• UDI-Public: (01)00380652390965(17)240630(11)190802(10)12730104
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: TFNT50
• Device Catalogue Number: TFNT50.145
• Device Lot Number: 12730104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/13/2024
• Date Device Manufactured: 08/02/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown