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	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced starburst, and halos around lights.Consumer's doctor did a lens exchange in both eyes with the company lens.Doctor did do a laser treatment to try to help but it made it worse both eyes.Consumer can't drive at night because of the oncoming lights and all the starbursts and halos, everything is distorted.There are two medical device reports associated with this event.This report is associated with the left eye.Additional information was requested and received that symptoms started immediately after surgery.Has seen retinal specialist and findings were normal.Using special sun glasses to function indoors.Has left his job because of debilitating glare and impact on daily living activities.Has seen different second opinion surgeons.Has been on vuity drops with no improvement over time.Does not recommend iol exchange.

• 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: 15864715
• Report Number: 1119421-2022-02482
• Device Sequence Number: 17869893
• Product Code: MFK
• UDI-Device Identifier: 00380652429719
• UDI-Public: 00380652429719
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2022

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: 05/31/2024
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.200
• Device Lot Number: 12720027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 11/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2019
• 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: 57 YR
• Patient Sex: Male