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	Visual Impairment (2138); Visual Disturbances (2140); Unspecified Eye / Vision Problem (4471)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis; it remains implanted.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A patient reported that following bilateral intraocular lens (iol) implant procedures, he experienced severe glare and starbursts to the degree that he no longer feels safe driving at night.The patient reported he had prior bilateral lasik procedures.The patient has provided additional information that he began experiencing problems immediately after the lenses were inserted.Currently he is unable to drive at night and during a normal sunny day he feels like his eyes are permanently dilated.He has to wear sunglasses all the time when outside if it's not overcast.Additionally, he is seeing ghost images around objects in his field of view, more pronounced at night.The patient has discussed these issues with his surgeon.He does not believe that lenses are at fault here.The patient believes that certainly the interaction between the prior lasik and the lenses are the problem.Even with his pupils almost completely closed he is uncomfortable in normal daylight.Driving is uncomfortable in the daytime, and unsafe at night.Halos, starburst and ghost images are the problems.His surgeon has referred him back to his lasik doctor and he had an appointment with her.Her feedback was not favorable for resolution of the issues.There are two medical device reports associated with this patient.This report is associated with the right eye.

• 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
• MDR Report Key: 11514446
• Report Number: 1119421-2021-00575
• Device Sequence Number: 19790712
• Product Code: MFK
• UDI-Device Identifier: 00380652414975
• UDI-Public: 00380652414975
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: 08/31/2024
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U190
• Device Lot Number: 12743572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR