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

Model Number	TFNT00
Medical Device Problem Codes	Failure to Fold (1255); Product Quality Problem (1506)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product 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).
Event or Problem Description
A pharmacist reported that the implant bends in the incorrect direction.Additional information has been requested but no information is available at the time of this report.
Additional Manufacturer Narrative
Corrected information was provided in h6.On initial mdr submitted the product code should be a040603 instead of a0201.Additional information was provided in b2, b3, b5 and d10 and h.11.Based on available information following submission of the initial report, this event does not meet criteria for reporting as a malfunction per regulation.No further reports required.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received stating that the incident occurred during preparation of the implant, before injection, during advancement of the implant.There was no contact with the patient¿s eye.The surgery was completed the same day with the replacement lens.

• 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: 25018747
• Report Number: 1119421-2026-00916
• Device Sequence Number: 10332450
• Product Code: MFK
• UDI-Device Identifier: 00380652357722
• UDI-Public: (01)00380652357722(17)300128(11)250130(10)15986317
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.195
• Device Lot Number: 15986317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/26/2026
• Date Device Manufactured: 01/30/2025
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM.; DUOVISC VISCOELASTIC SYSTEM.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.
• Patient Sex: Unknown