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

Model Number	TFNT30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/27/2025
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.Three photos were provided.The first photo showed a yellow lens adhered to the inside of a lens case lid with viscoelastic.Both haptics were broken-gusset area, broken portions not in picture.The second and third photos showed the same image.The lens case lid was shown from the label side.The yellow lens was beside the lens case lid.Viscoelastic was visible on the lens.Both haptics were broken-gusset area, broken portions not in picture.The optic had been cut from the edge through the center typical of removal.A determination for the cause of the haptic damage cannot be made from the photo.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-health care professional reported that during intraocular lens (iol) implantation surgery the lens came out of the cartridge with one haptic broken.The physician was unable to implant the damaged iol which had to be removed into two parts.The patient was waiting for another lens implantation surgery.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6., and h.11.The product was not returned.Photos were provided that show a yellow lens with viscoelastic on it, and both haptics broken-gusset area.The optic had been cut from the edge through the center typical of removal.A determination for the cause of the haptic damage cannot be made from the photo.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.The account indicated the use of a qualified associated cartridge and handpiece with a non-qualified viscoelastic.Based on our observation of the attached photos, the haptic is broken and clinical solution appears to be present on the lens.The root cause for the reported complaint may be related to a failure to follow the ifu (instructions for use).The viscoelastic indicated is not qualified for the company combination used.The ifu instructs that an alcon qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The account indicated the product was not available to evaluate.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: 23908256
• Report Number: 1119421-2025-03277
• Device Sequence Number: 10024669
• Product Code: MFK
• UDI-Device Identifier: 00380652389976
• UDI-Public: (01)00380652389976(17)280808(11)230811(10)15695079
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: TFNT30
• Device Catalogue Number: TFNT30.200
• Device Lot Number: 15695079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/19/2026
• Date Device Manufactured: 08/11/2023
• 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 C.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; OFT VISC 2%.
• Patient Age: 64 YR
• Patient Sex: Male