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

Model Number	TFNT50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.Root cause has not been identified.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following the intraocular lens (iol) implantation, the patient was not able to see without glasses, had starbursts to the point where he immediately had to stop night driving did not have this problem before the surgery was performed.He could not see clearly at 10¿, such as the guide on the tv and was not able to focus on things he could see.Nothing could be done to correct any of this.Additional information was requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating, the patient was not happy with the lenses as the vision was not good and could not drive at night.The right eye was out of focus and with the left eye cannot see distance.The close up vision was not clear as well.Had to come back to wearing the bi-focal glasses again.Additional information was reported by the customer stating some of her issues have improved, but overall, she's unable to function without glasses and was very dissatisfied with lens.This report is for the left eye.

• 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: 11968457
• Report Number: 1119421-2021-01180
• Device Sequence Number: 17198331
• Product Code: MFK
• UDI-Device Identifier: 00380652416726
• UDI-Public: 00380652416726
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2021

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: 09/30/2024
• Device Model Number: TFNT50
• Device Catalogue Number: TFNT50U270
• Device Lot Number: 12746897
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 08/01/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/22/2021
• 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