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

Model Number	TFNT40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Headache (1880); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Discomfort (2330); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/12/2021
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
An account manager reported on behalf of surgeon that, following intraocular (iol) lens implantation, the patient felt uncomfortable, the antibiotic medication also burned really bad when she puts in.Three weeks post iol implantation, the patient was seeing pretty well, however, was still having halos, peripheral haze and headaches too.Patient was using a corticosteroid eye drop.The patient also experienced stinging and aching in the left eye that comes and goes since surgery and also had a black eye under her eye.Six weeks post operation, eye still hurts and it felt like a migraine in her eye with foreign body sensation, very photophobic, still had halos that were not improving at all.Nine weeks post-op, her vision was doing fine except halos and glare.The patient was continuing with antibiotics, anti-inflammatory drug and corticosteroids.Six months post-op the context was reported as driving, watching tv, while reading; severity is described as moderate.Patient described the following signs and symptoms: still has glare, her distance vision is not great some days and cannot see to read well in real life situations like reading a cookbook.No medications were reported that were continued.There was a mild posterior capsule opacity observed.The patient's visual symptoms include: trouble driving at night because of glare, trouble doing near work like threading a needle or reading fine print, bad trouble seeing street signs while driving.Additional information was provided and patient stated that they are still having continuous glare, fog, halos and headache every day for 6 months.Patient had to buy readers because near vision was not good.There are two medical device reports associated with this patient.This report is associated with the left eye.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12462343
• Report Number: 1119421-2021-01740
• Device Sequence Number: 3924993
• Product Code: MFK
• UDI-Device Identifier: 00380652415958
• UDI-Public: 00380652415958
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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: 07/31/2024
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40U150
• Device Lot Number: 12731936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ORA SYSTEM WITH VERIFEYE MESSAGING; ORA SYSTEM WITH VERIFEYE MESSAGING, CART; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR