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	Conjunctivitis (1784); Vitreous Floaters (1866); Itching Sensation (1943); Uveitis (2122); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Confusion/ Disorientation (2553); Eye Infections (4466); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following a cataract extraction with intraocular lens (iol) implant procedure, the patient experienced episodes of retinal uveitis with a grey cloud going back and forth in both eyes.The patient also has sensitivity to fluorescent lights.The lenses have completely disrupted patient life.The patient did not drive at night, and reading was difficult.Additional information was received stating shortly after implants, vision was distorted with huge gray floaters in both eyes, pink conjunctiva, watery, itchy, difficulty focusing.The corticosteroid eye drops started with improvement, then symptoms worsened, and included halos around lights.The grey haze continued and the yttrium aluminum garnet (yag) laser performed with little improvement.The cholinergic agonist eye medication was used for 5 weeks without improvement.Over several months, patients have had little relief and also had eye infections, scleritis of right eye.The lacrimal plugs placed on eyes were tearing.The patient saw retinal specialist, no infectious process, but large amounts of debris in vitreous and was diagnosed with uveitis.The patient had a 2nd ophthalmology opinion (cataract dr.) advised since yag laser done, would be difficult to exchange lenses.The patient developed issues with fluorescent lights-eyes tear, feel swollen, feeling of disorientation due to vision.The retinal specialist said this was due to lenses.The patient ends up wearing sunglasses in the grocery store, gym, etc.The patient remains on corticosteroids eye drops for the right eye.There are two medical device reports associated with this patient.This report is for right eye.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.Root cause has not been identified.There has been no other complaint reported in the lot number.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: 15454633
• Report Number: 1119421-2022-02006
• Device Sequence Number: 6842057
• Product Code: MFK
• UDI-Device Identifier: 00380652415002
• UDI-Public: 00380652415002
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2022

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: 05/27/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U205
• Device Lot Number: 15073043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2020
• 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: 67
• Patient Sex: Unknown