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

Model Number	TFNT40
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.No other complaint reported in the lot.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¿s vision dropped from 1.0 to 0.2 down.The surgeon seen the haptic has been placed above the iris and the also thought that there is a possibility of eye structure has weakened.The lens exchanged in a secondary procedure.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens is cut in half, typical of insertion and removal from the eye.Cracks are observed in the haptic optic junction area.One slit lamp photo was submitted for review.The photo is a broad parallelepiped focused at the level of the anterior surface of the iol.Concentric rings are clearly visible which are representative of a company lens.Only a small segment (approximately 1-2 clock hours) of the lens is visible.No abnormalities are noted in this lens segment.Significant reflections from the corneal surface preclude any corneal analysis.No root cause of the patient¿s decreased vision can be ascertained from the photo.Associated products were not provided.It is unknown if qualified products were used.A malfunction has not been indicated or information provided that the lens was the cause of the event.Information was provided that the surgeon observed the haptic was placed above the iris and the surgeon thought that there is a possibility that the eye structure (capsule bag & zonula) has also weakened so that the lens exchange procedure was performed.The manufacturer internal reference number is: (b)(4).

• 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: 15349473
• Report Number: 1119421-2022-01897
• Device Sequence Number: 17522507
• Product Code: MFK
• UDI-Device Identifier: 00380652390545
• UDI-Public: 00380652390545
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: 11/10/2025
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40.210
• Device Lot Number: 15111578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown