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 Code	Visual Impairment (2138)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There are 2 medical device reports associated with this event.This report is for the left eye.There have been no other complaints reported in the lot number.Additional information received stated that the replacement lens was used.Surgery was performed for iol exchange.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A patient reported that post implantation of an intraocular lens (iol) patient experienced lights inside eyes especially when reading and light seems to bounces off the pages, flickering and glare.The lens was exchanged in the secondary procedure with the new lens.There are 2 medical device reports associated with this event.This report is for the left eye.Additional information received stated that the replacement lens was used.Surgery was performed for iol exchange.

• 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: 11893625
• Report Number: 1119421-2021-01116
• Device Sequence Number: 1388252
• Product Code: MFK
• UDI-Device Identifier: 00380652414920
• UDI-Public: 00380652414920
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

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: 07/07/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U165
• Device Lot Number: 15080622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/27/2021
• 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: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR