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

Model Number	TFNT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.The 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.Additional information has been requested.(b)(4).
Event or Problem Description
A facility representative reported that after the initial intraocular lens (iol) implant procedure, a patient complained of "glare" and a clinical reason of "glare".This required the removal of the iol in a secondary surgery.Additional information has been requested.
Additional Manufacturer Narrative
Associated products were not provided.It is unknown if qualified products were used.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
This is a duplicate of manufacturer report number 1119421-2021-00598.No additional reports will be filed on this report number.Any additional information that is received will be reported on manufacturer report number 1119421-2021-00598.The manufacturer internal reference number is: (b)(4).

• 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: 11609927
• Report Number: 1119421-2021-00735
• Device Sequence Number: 3262980
• Product Code: MFK
• UDI-Device Identifier: 00380652415569
• UDI-Public: 00380652415569
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2021

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: 04/30/2025
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30U220
• Device Lot Number: 15068250
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 05/19/2021; 09/23/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/21/2021; 10/13/2021
• 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: Required Intervention