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

Model Number	TFNT00
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2025
Type of Reportable Event	Serious Injury
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 health care professional reported that 5 years 11 months 4 days ago the patient underwent cataract and intraocular lens (iol) implant procedure.Following that, the patient returned to the clinic and the lens was examined within the eye, and it was decided to have it replaced.The iol was exchanged for another lens 5 years 11 months 15 days following the initial implant procedure.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.Product evaluation: the lens was returned sealed inside a small non-company blue pouch.Viscoelastic was dried on the lens.The optic was torn (cut) and split from the edge to beyond the optic center.The lens was cleaned with klotho-related protein (klrp) for further evaluation.A small area of cracked damage was also observed near the optic center.A retest of the power and resolution could not be conducted due to the damage through the optic rings of the lens.Product history records were reviewed and documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified products were used.Root cause: the root cause cannot be determined for the reported complaint.A specific product malfunction was not alleged and a clarification of the event was not provided.The returned sample had been cut from edge to beyond the optic center, typical in appearance to damage from an insertion and removal of an intraocular lens (iol).Additional optic damage was observed.Each lens was subjected to a 100% 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.Information in the file indicated that the initial implant was in 2019 and the patient returned in 2025.The complaint indicated that the lens was examined within the eye and decided to explant.The company 21.5 diopter (add power +2.2/+3.2 diopter) was removed and replaced.The replacement lens information was not provided.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to request for follow-up information.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• 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: 22477389
• Report Number: 1119421-2025-01887
• Device Sequence Number: 8016328
• Product Code: MFK
• UDI-Device Identifier: 00380652357760
• UDI-Public: (01)00380652357760(17)230831(11)180911(10)12650600
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: 08/31/2023
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.215
• Device Lot Number: 12650600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown