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

Model Number	TFNT40
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Additional information has been requested.(b)(4).
Event or Problem Description
A health professional reported that after an intraocular lens (iol) implant surgery, the lens presented with glistenings.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in h.3., and h.10.The product was not returned.The provided photos were reviewed by global device medical safety ¿ gdms: evaluation of provided picture: toric iol in place with many opacified spots different in size but detectable.It is difficult to confirm if the eye went through inflammation based on quality of two other photos.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided from the account for further investigation.Information was provided by a facility representative that, "the finding on the company 21.0 d intraocular lens is not subjectively or objectively evoked difficulties, therefore only observation is appropriate.If the finding worsens, appropriate explanation of the iol and secondary implantation of another type of intraocular lens.".Photo evaluation by global device medical safety - gdms: evaluation of provided picture: toric iol in place with many opacified spots different in size but detectable.It is difficult to confirm if the eye went through inflammation based on quality of two other photos.A conclusion regarding the nature and the origin of the observation can not be determined from a photo assessment.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in a.2., a.3.A., b.3., d.3., d.4.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in b.5., e.1., h.3., h.6.And h.11.The product was not returned.The provided photos were reviewed and toric intraocular lens (iol) in place with many opacified spots different in size but detectable.It is difficult to confirm if the eye went through inflammation based on quality of two other photos.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.A root cause cannot be determined without physical examination of the product.It is difficult to confirm if the eye went through inflammation based on quality of two other photos.Information was provided by a facility representative that, "the finding on the iol company 21.0 d intraocular lens is not subjectively or objectively evoked difficulties, therefore only observation is appropriate.If the finding worsens, appropriate explanation of the iol and secondary implantation of another type of intraocular lens." the reporting facility has not provided any further information.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received stating during an objective examination of the eye, numerous vacuoles were observed in the optical part of the lens, which had newly formed in the material of the intraocular lens in the right eye the so-called glistening.The patient has no subjective problems.Outcome of incident was reported as without deterioration of health.

• 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: 10079368
• Report Number: 1119421-2020-00787
• Device Sequence Number: 16907520
• Product Code: MFK
• UDI-Device Identifier: 00380652390545
• UDI-Public: (01)00380652390545(17)231130(11)181213(10)12673526
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/09/2025

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: 11/30/2023
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40.210
• Device Lot Number: 12673526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 06/28/2020; 02/07/2025; 03/12/2025
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 06/29/2020; 03/07/2025; 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 56 YR
• Patient Sex: Female