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

Model Number	TFNT40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The patient indicated the surgeon has planned a lasik blasting technique to treat hazy vision.No further information has been provided at this time.File will be reopened when new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that she had surgery on (b)(6) 2024 and was so disappointed with these lenses.Experienced halo's all the time and did not have clear vision.She was shocked that there was a (b)(4) satisfaction in these lenses.There was a possibility of needing glasses after but consumer was told the glasses can't help her problem.Additional information has been requested and received stating that the symptoms had not been resolved.They were trying lasic blasting techniques to get rid of the haze over my eyes.She still had horrible halos in both the eyes that had not resolved.There are two medical device reports associated with this patient.This report is associated with the right 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19048943
• Report Number: 1119421-2024-00627
• Device Sequence Number: 8483085
• Product Code: MFK
• UDI-Device Identifier: 00380652390316
• UDI-Public: 00380652390316
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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: 04/06/2026
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40.095
• Device Lot Number: 15178446
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female