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

Model Number	TFNT00
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported during an intraocular lens (iol) implant procedure, the lens was stiff end was not coming right out of the cartridge.Additional information was requested.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in b.5., d.9., d.10., h.3., h.6.And h.11.The lens was not returned stuck in a cartridge as described.The lens was returned positioned incorrectly posterior side up in the lens case.Solution was dried on the lens.Both haptics were in a folded position, adhered to the optic surface by solution.The lens was removed from the lens case and cleaned with klrp for further evaluation.Both haptics were pliable when manipulated.No issues observed.A fold inspection was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.A dimensional (plan view) inspection was conducted and the lens met specification per the approved (plan view) template.The qualified associated cartridge was not returned for evaluation.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.Qualified associated products were indicated.The root cause may be related to a failure to follow the ifu.Information was provided that temperature in the operating room was 17.8° c.This temperature is outside the recommended range the ifu instructs: use the company cartridge at operating room temperatures between 18 degrees celsius (64 degrees fahrenheit) and 23 degrees celsius (73 degrees fahrenheit).The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received confirming that there was no adverse effects reported.

• Brand Name: ACRYSOF IQ PANOPTIX 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: 23005522
• Report Number: 1119421-2025-02427
• Device Sequence Number: 9702566
• Product Code: MFK
• UDI-Device Identifier: 00380652357784
• UDI-Public: (01)00380652357784(17)290720(11)240722(10)15892515
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 10/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.225
• Device Lot Number: 15892515
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/22/2025
• Date Device Manufactured: 07/22/2024
• 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 CARTRIDGE D.; MONARCH III IOL INJECTOR.; PROVISC OVD.
• Patient Sex: Female