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

Model Number	TFAT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, the patient has trouble reading, seeing distance, can't drive at night.She notes flickering and new floaters.Has trouble seeing in dim lights in the house.She notices her other eye is doing all the work.She is seeing better through her weaker eye.Her surgeon was surprised and could not figure out what the issue for her is.There was nothing wrong with the lens or her eye as far as he could tell.He gave her a glasses prescription.Additional information has been requested, received and stated the patient had vision issues one month post implantation.In the surgeon's opinion, the product did not cause or contribute to the event.There was no patient harm.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that a qualified cartridge and handpiece were used with a non-qualified viscoelastic.This would not be related to the reported issue.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The reporter (patient) has an appointment scheduled for (b)(6) 2024.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated fluorescent lights still an issue for patient.Sunglasses relieved the issue.The patient was able to play golf, pickleball, tennis, drive and read.Saw a physician for second opinion.She was not confident in visit.The physician told her it would take a very long time to recover from a second eye surgery.The patient will have a third opinion.
Additional Manufacturer Narrative
Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX UV ABSORBING 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: 18825623
• Report Number: 1119421-2024-00384
• Device Sequence Number: 7785741
• Product Code: MFK
• UDI-Device Identifier: 00380652429702
• UDI-Public: 00380652429702
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.195
• Device Lot Number: 15455890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 04/15/2024; 06/26/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 05/13/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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: AMVISC OVD.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female