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

Model Number	TFNT30
Medical Device Problem Codes	Material Opacification (1426); Material Deformation (2976)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information was provided in h.3.,h.6 and h.11.A clinical review was conducted for the provided photo.An image of an iol was provided with a question of association with glistenings and a report of, some sort of haziness over the posterior aspect of the lens.The haziness in the photo appears more confluent than the characteristic appearance of microvacuoles associated with glistenings, and the location would be throughout the bulk of the lens compared to the posterior aspect reported.A cause or association of this appearance with the complaint product was not able to be determined based on the images and further assessment would be necessary to accurately identify these findings and determine their significance in relation to the associated product investigation.Not enough information was provided for further investigation.The clinical review of the provided photo indicated that the haziness in the photo appeared more confluent than the characteristic appearance of microvacuoles associated with glistenings, which would be throughout the bulk of the lens compared to the posterior aspect reported.A cause or association of this appearance with the complaint product was not able to be determined based on the images and further assessment would be necessary to accurately identify these findings and determine their significance in relation to the associated product investigation.Due diligence has been performed in an attempt to obtain further information on this event.The facility has not responded to requests for follow-up information.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
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's internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure, patient experienced glistenings and feels like his vision is getting worse.There was some sort of haziness over the posterior aspect of the lens.The patient had yag (yttrium aluminum garnet) procedure and possibly vitrectomy for floaters.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned.A clinical review was conducted for the provided photo.An image of an intraocular lens (iol) was provided with a question of association with glistenings and a report of, some sort of haziness over the posterior aspect of the lens.The haziness in the photo appears more confluent than the characteristic appearance of microvacuoles associated with glistenings, and the location would be throughout the bulk of the lens compared to the posterior aspect reported.A cause or association of this appearance with the complaint product was not able to be determined based on the images and further assessment would be necessary to accurately identify these findings and determine their significance in relation to the associated product investigation.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The product investigation could not identify a root cause for the reported complaint.The product was not returned.A clinical review of the provided photo indicated that the haziness in the photo appeared more confluent than the characteristic appearance of microvacuoles associated with glistenings, which would be throughout the bulk of the lens compared to the posterior aspect reported.A cause or association of this appearance with the complaint product was not able to be determined based on the images and further assessment would be necessary to accurately identify these findings and determine their significance in relation to the associated product investigation.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.
Additional Manufacturer Narrative
Additional information was provided in a.1., a.2., a.3.A., b.5., b.6, b.7., d.1., d.4., d.6.A and d.10.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, in the surgeon prognosis overall ocular health was normal.The glistenings on the posterior surface of the intraocular lens (iol) seem to be limiting vision.There are two medical device reports associated with this patient.This report is associated with the left eye.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 21856298
• Report Number: 1119421-2025-01070
• Device Sequence Number: 4719406
• Product Code: MFK
• UDI-Device Identifier: 00380652415545
• UDI-Public: (01)00380652415545(17)250421(11)200422(10)15066706
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/09/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2025
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30U210
• Device Lot Number: 15066706
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 06/04/2025; 10/17/2025; 11/18/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/26/2025; 11/07/2025; 12/09/2025
• Date Device Manufactured: 04/22/2020
• 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 DELIVERY SYSTEM, CARTRIDGE D; ORA SYSTEM WITH VERIFEYE MESSAGING; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; UNSPECIFIED FORCEPS; UNSPECIFIED INJECTOR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male