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 Codes	Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not been returned to the manufacturing site.Based on the results from the product and batch history record, the product met release criteria.Root cause cannot be identified at this time.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
It was reported by a consumer that he was not happy with the lens implant, and has been suggested to remove lens and insert a different lens.Patient had a steamy, smokey vision od.He states surgeon did prk to help clear it up with no improvement.He was then referred to retina specialist and had a vitrectomy with no improvement.He is being advised now, he likely needs an iol exchange.He does not know his sn nor does he know the date of surgery.He did provide the surgeon name, and facility where it was done.Additional information requested.

• 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: 12106765
• Report Number: 1119421-2021-01304
• Device Sequence Number: 3705068
• Product Code: MFK
• UDI-Device Identifier: 00380652415347
• UDI-Public: 00380652415347
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

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: 04/30/2024
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30U110
• Device Lot Number: 12712813
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 07/02/2021
• 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
• Patient Age: 61 YR