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

Model Number	TFNT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
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
A facility representative reported following an intraocular lens (iol) implant procedure, the patient experienced blurry distance vision and feels like something in eye.The lens was explanted and replaced with same model lens with unknown diopter in a secondary procedure.The clinical reason for the explant was blurry distance vision not improving.Additional information was requested.
Event or Problem Description
Additional information has been received and stated that intraocular lens moved forward leaving patient with myopic error.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution and blood are dried on the lens.The lens is cut in half, typical of insertion and removal from the eye.A power and resolution inspection could not be conducted due to extensive damage.Product history records were reviewed, and the documentation indicated the product met release criteria.The file indicates the use of a qualified cartridge and handpiece.The file also indicates the use of a non-qualified viscoelastic.The product investigation could not identify a root cause for the reported complaint.A power and resolution inspection could not be conducted due to extensive damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.The explanted lens was replaced with the same model and diopter lens.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: 18744879
• Report Number: 1119421-2024-00316
• Device Sequence Number: 6509644
• Product Code: MFK
• UDI-Device Identifier: 00380652389990
• UDI-Public: 00380652389990
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2026
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30.210
• Device Lot Number: 15218127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2021
• 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: ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL; AMVISC PLUS; MONARCH III CARTRIDGE D; MONARCH III INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown