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

Model Number	TFAT60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
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
Nurse reported that following an intraocular lens (iol) implant procedure, the patient experienced glare and poor vision, despite yttrium aluminum garnet (yag) laser capsulotomy the iol was exchanged for monofocal iol lens 1 year 2 months 3 weeks 2 days following the initial implant procedure.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned in a non-company peel pouch.Solution was dried on the lens.The optic was cut into pieces, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.Product history records were reviewed and documentation indicated the product met release criteria.File indicated the use of a qualified cartridge and handpiece with a non-qualified viscoelastic.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100 percent assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Power and resolution could not be reverified due to the extensive optic damage.Information was provided that the multifocal toric company 20.0 diopter (3.75cylinder) add power +2.2 & 3.2 lens model was replaced with a monofocal non-company 19.5 diopter lens.Due to the exchange of a multifocal lens to a monofocal lens, may suggest that the replacement lens model was an improved choice for the patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21619461
• Report Number: 1119421-2025-00705
• Device Sequence Number: 8446355
• Product Code: MFK
• UDI-Device Identifier: 00380652420297
• UDI-Public: (01)00380652420297(17)250210(11)200212(10)15032332
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: 02/10/2025
• Device Model Number: TFAT60
• Device Catalogue Number: TFAT60.200
• Device Lot Number: 15032332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2020
• 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 LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; OVD: AMVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown