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); Halo (2227)
Date of Event	01/11/2023
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.Information was provided that indicated the use of a qualified cartridge, handpiece, and viscoelastic.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the 19.5 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non-company monofocal 20.0 diopter lens.This information suggests that the replacement lens model and diopter may have been an improved selection for this patient's vision needs or preferences.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-health care professional reported following the intraocular lens implantation the lens was explanted in a secondary procedure.The reason for the explant was blurry vision and unhappy with vision.Additional information has been requested and received stating the patient reported that the vision was not crisp or sharp, and had halos.There was no harm to the patient and the symptoms have resolved.The prognosis was excellent.There are two medical device reports associated with this patient.This report is for the left eye.

• 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: 16627794
• Report Number: 1119421-2023-00550
• Device Sequence Number: 4551274
• Product Code: MFK
• UDI-Device Identifier: 00380652357722
• UDI-Public: 00380652357722
• 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: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2023

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: 10/29/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.195
• Device Lot Number: 15111692
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• 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 II IOL CARTRIDGE B; MONARCH II IOL INJECTOR; PROVISC; REPLACEMENT LENS: MX60E: + 20.0D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female