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

Model Number	TFAT60
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Blurred Vision (2137); Diplopia/Double Vision (4802)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The report was received from a government agency sharing a medwatch form, to report a problem received from a patient that, doctor performed cataract surgery with company multi focal lens in both the eyes.The lens in the left eye had never worked.The new lens had caused double vision and blurred vision in the left eye.Reported this to the doctor and he said that the new lens wrinkled when it was inserted.He performed another surgery to correct the wrinkle.That did not correct the problem.Consulted two other eye doctors, and they agreed that the lens was not working but did not tell why the lens did not work.There was a speculation as to why the blurred and double vision.Problem could be that the wrong lens was used in the left eye; doctor's assistant could have handed him the wrong lens, lens might have not been correctly marked in the package but bottom line the vision was not correct in the left eye.The doctor that he was seeing prescribed a contact lens that must be worn daily.This was a correction lens.But as per the patient, the cataract surgery should have corrected the vision and should not have to buy contact lens forever to correct the vision that should have been corrected with the cataract surgery.Additional information has been requested and received stating that the double vision, he could see two images.One image and a second image at the 11 o clock position.Additional information has been provided stating that he started experiencing symptoms immediately after the surgery in the left eye.He informed that he would visit doctor on a regular basis.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 has been provided in h.3., and h.11.The product was not returned.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 product investigation could not identify a root cause for the reported complaint.The lens remains implanted.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The reporter was the patient.The lens was implanted (b)(6) 2020.Reporter indicated issues were noted immediately after the surgery.It is unclear what surgery was conducted for the reported "wrinkled" lens.This may have been referring a capsular fold as the iol would not wrinkle.The reporter indicated the issue resolves with the use of a contact lens.It is unknown if the lens is at the targeted axis.Rotation of a toric iol away from its intended axis can reduce the astigmatic correction.Each degree of misalignment of a toric iol may reduce the cylinder power effect by approximately 3.3%.The surgeon has not responded to the request for follow up information.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC UV ABSORBING 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: 22608806
• Report Number: 1119421-2025-02051
• Device Sequence Number: 9564731
• Product Code: MFK
• UDI-Device Identifier: 00380652420211
• UDI-Public: (01)00380652420211(17)240630(11)190730(10)12725110
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: TFAT60
• Device Catalogue Number: TFAT60.160
• Device Lot Number: 12725110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 10/03/2025
• Date Device Manufactured: 07/30/2019
• 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; Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 118 KG