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	Blurred Vision (2137)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product evaluation: the product was not returned.All product and batch history records are quality reviewed prior to product release.The product investigation could not identify a root cause for the reported complaint.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
The representative reported that a patient was bilaterally implanted with panoptix.Now 4 months po ¿ distance vision r & l 6/6, binocularly 6/4.8, reads n4.Happy with daylight vision but cannot tolerate night vision.Surgeon planning explanted of iol on (b)(6) 2021.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received, and stated, that symptoms resolved post operation.

• 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: 12240274
• Report Number: 1119421-2021-01487
• Device Sequence Number: 19715704
• Product Code: MFK
• UDI-Device Identifier: 00380652389846
• UDI-Public: 00380652389846
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2021

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: 03/31/2024
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30.135
• Device Lot Number: 12706914
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 07/12/2021; 09/09/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/09/2021; 10/04/2021
• 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