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 Code	Blurred Vision (2137)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product was not returned for analysis.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that after surgery the patient experienced the symptom that appears cloudy after surgery it became more severe and the exchange was conducted and the patient also experiencing worsening blurred vision leading to an exchange being performed.The intraocular lens (iol) was subsequently removed and replaced with unspecified replacement lens during initial implantation procedure and procedure was completed on the same day.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
Additional information was provided in d.9, e.4., h.3., h.6.And h.11.The lens was returned inside a clear, plastic tray.Solution was dried on the lens.The optic was cut from the edge extending across the optic center.The anterior optic surface was scratched in the optic center.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.A photo was provided that matched the condition of the returned sample.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.A qualified cartridge and handpiece were indicated with an unknown viscoelastic.The root cause cannot be determined for the reported complaint.The explanted lens was returned cut from the optic edge through the optic center.An anterior optic scratch was also observed.Each lens was subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.The lens was implanted 25-feb-2021, the patient experienced worsening blurred vision, leading to an exchange being performed.The replacement lens information was not provided.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; 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: 25348110
• Report Number: 1119421-2026-01171
• Device Sequence Number: 13337734
• Product Code: MFK
• UDI-Device Identifier: 00380652389969
• UDI-Public: (01)00380652389969(17)250122(11)200124(10)15009710
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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: 01/22/2025
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30.195
• Device Lot Number: 15009710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2020
• 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 III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; UNSPECIFIED VISCOELASTIC (OVD)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male