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)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision and unexpected refraction.Additional information received that the lens was explanted.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received that the iol was exchanged for the monofocal lens model of same diopter indicating there was no issue with the lens power.There is no reported defect or fault with the iol.
Additional Manufacturer Narrative
Additional information provided in b.2., b.5.And h.11.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a (serious injury).No further reports required.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: 19483397
• Report Number: 1119421-2024-01088
• Device Sequence Number: 7976867
• Product Code: MFK
• UDI-Device Identifier: 00380652357739
• UDI-Public: 00380652357739
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2024

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 Model Number: TFNT00
• Device Catalogue Number: TFNT00.200
• Device Lot Number: 15599964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 06/30/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/29/2024
• Date Device Manufactured: 03/21/2023
• 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