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

Model Number	TFNT00
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/08/2022
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 physician reported that following the cataract surgery with intraocular lens (iol) implant procedure, the patient had smeary vision, waxy appearance.Hence iol was explanted and replaced with non company iol to match other eye.Pre-explant vision was (b)(6).Had mild posterior capsule opacification (pco) but surgeon didn¿t feel explained symptoms so proceeded with explant.Had yttrium, aluminum and garnet (yag) capsulotomy.Additional information has been requested.Additional information received and stated that the patient complained of ripple or water effect over vision.Iol centration and examination normal.Reviewed on 22-nov-2022, minor pco was observed.No resolution in symptoms hence booked for iol exchange.Iol exchange performed on (b)(6) 2022 with non company iol.Following the exchange of iol the patient reported resolution of symptoms.On (b)(6) 2023 yttrium aluminum garnet (yag) was performed.
Additional Manufacturer Narrative
The product investigation could not identify a root cause for the reported complaint.The product was not returned.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 lens was replaced with a non-company lens to match the fellow eye.After some critical analysis of the case, hcp believes that the patient¿s difficulties related to a highish angle kappa/alpha and thus, the iol centration was the issue with the patient¿s satisfaction.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that patient¿s difficulties related to a highish angle kappa/alpha and thus, the iol centration was the issue with the patient¿s satisfaction.

• 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: 16378486
• Report Number: 1119421-2023-00326
• Device Sequence Number: 15002864
• Product Code: MFK
• UDI-Device Identifier: 00380652357753
• UDI-Public: 00380652357753
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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 Model Number: TFNT00
• Device Catalogue Number: TFNT00.210
• Device Lot Number: 15347034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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: IOL EXCHANGE SYMFONY.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown