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

Model Number	TFNT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, he is having trouble with the close vision, and it was blurry, he cant focus on the near reading and its deteriorating each week.Additional information has been received stated that the close focal point (0-10 feet) continues to deteriorate and reading or close up work is no longer possible with the right eye and since the implant the vision is increasingly cloudy in the right eye when viewing objects against a light background.No further information available.Additional information has been received stated that posterior capsule haze was reported.
Event or Problem Description
Addition information has been received stated that reading vision increasing blurry and basically not functional unless in bright light and then it remains blurry.The 0-10 foot range was also worse and was not able to focus clearly although once again better in bright light.The intermediate distance approximately 10 feet to 60 feet is now blurry at all times and was unable to focus clearly regardless of the time allowed.The far distance is now also blurry at all times and was unable to focus clearly regardless of the time allowed.A bluish tinge is now noticeable particularly when looking at lighter backgrounds with the company lens compared to the natural lens.The company lens are much worse with dim light.In very dim or dark surroundings the lens is basically nonfunctional other than to detect movement.No further information available.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX 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: 16022205
• Report Number: 1119421-2022-02706
• Device Sequence Number: 6960668
• Product Code: MFK
• UDI-Device Identifier: 00380652415026
• UDI-Public: 00380652415026
• 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
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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: 02/29/2024
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U215
• Device Lot Number: 12694761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 01/02/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male