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	Red Eye(s) (2038); Blurred Vision (2137); Halo (2227); Irritability (2421)
Date of Event	12/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.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 manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following the cataract surgery with intraocular lens (iol) implant procedure, the patient experienced blurred and halo effects.Had problems reading small print and grocery shopping price lists.Had yttrium aluminium garnet (yag) posterior capsulotomy to no good results.The patient was being told that there is nothing else to do, he has to live with-it and patient stated that can not see.There are two medical device reports associated with this event.This report is associated with the 2 of 2.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was received on a.2., b.3., b.5., d.1., d.4., d.6.A., e.4.And h.4.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that, after a month of surgery the patient started having the symptoms.It was also stated cant see and it was everything blurred.
Additional Manufacturer Narrative
Corrected information provided in b.5., h.6 (fda patient event codes).Additional information provided in h.3., h.6.And h.10.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 reporter is the patient.Symptoms started one month after surgery.The hcp has not responded to request for further information.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that, after a month of surgery the patient started having the symptoms.It was also stated that patient had redness, itch, halos and cant see and it was everything blurred.

• 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: 16253625
• Report Number: 1119421-2023-00205
• Device Sequence Number: 14770669
• Product Code: MFK
• UDI-Device Identifier: 00380652429702
• UDI-Public: 00380652429702
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2023

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 Expiration Date: 11/30/2024
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.195
• Device Lot Number: 12766326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/31/2022
• Supplement Date Received by Manufacturer: 02/09/2023; 03/09/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 03/09/2023; 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2019
• 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; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Unknown