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

Model Number	TFNT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
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 healthcare professional reported that, after intraocular implantation surgery, the patient was unhappy with the vision facing excessive light during the day time also.The patient experienced excessive bright and flashes around the eye.He also had difficulty reading hand writing on white paper, difficulty in distinguishing black letters on white board.Additional information has been requested and received stating that he experienced glare, poor reading ability in bright light, increased reflection of white light, halos to see signals and inability to read letters in white background.Issue was discovered after few days to months after surgery.The originally scheduled procedure completed on the same day.The nature of lens contributed to the event as per the surgeons opinion.Glare was due to lens optical design.The patients issues did not resolve.Surgeon planning an lens exchange.There are two medical reports associated with this patient.This file belongs to right eye.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Follow up attempts were made.The file will be reopened if additional information is provided.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information has been provided in d.4., d.10., h.6., and h.11.The file indicates the use of a non-qualified viscoelastic.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: 18911679
• Report Number: 1119421-2024-00491
• Device Sequence Number: 20589756
• Product Code: MFK
• UDI-Device Identifier: 00380652357760
• UDI-Public: (01)00380652357760(17)270717(11)220719(10)15455912(21)15455912028
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2024

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: TFNT00
• Device Catalogue Number: TFNT00.215
• Device Lot Number: 15455912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 05/01/2024; 10/08/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 05/29/2024; 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• 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: IRIVISC HPMC.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Male