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

Model Number	TFNT60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Conjunctivitis (1784); Hypersensitivity/Allergic reaction (1907); Visual Impairment (2138); Posterior Capsule Opacification (4807)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient was hyperopic and underwent laser-assisted in situ keratomileusis (lasik) procedure.The patient had hyperopic regression post lasik procedure and again back to hyperopic.The iol was exchanged for different model and different diopter company lens 3 years 2 months 25 days following the initial implant procedure.As per reporter the device did not cause or contribute to the event.Additional information has been received and stated that, post implantation of lens, the patient had allergic conjunctivitis, posterior capsular opacification.
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).
Additional Manufacturer Narrative
Additional information was provided in h.3 an h.11.A qualified cartridge was indicated with a handpiece.This would have been used with the replacement lens.It was not available in 2021 when the original lens was implanted.The product investigation could not identify a root cause for the reported complaint.The product was not returned.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 surgeon provide information that the patient was hyperopic after the lens implant in 2021.The patient underwent lasik in (b)(6) 2022 and had hyperopic regression and is now hyperopic again.The surgeon indicted that the product did not cause or contribute to the current event.The company suspect device (3.75cyl), 16.5 diopter lens was replaced with a company (3.75cyl), 18.0 diopter lens.The change in diopter of 1.5 may indicate the replacement lens was an improved choice for the patient's current visual needs.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
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; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20212127
• Report Number: 1119421-2024-01810
• Device Sequence Number: 7450185
• Product Code: MFK
• UDI-Device Identifier: 00380652417044
• UDI-Public: (01)00380652417044(17)231031(11)181109(10)12662790(21)12662790075
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2024

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: 10/31/2023
• Device Model Number: TFNT60
• Device Catalogue Number: TFNT60U165
• Device Lot Number: 12662790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 11/28/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/28/2024; 12/27/2024
• Date Device Manufactured: 11/09/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLAREON MONARCH IV INJECTOR; CLAREON PANOPTIX TORIC IOL; MONARCH III CARTRIDGE D; ORA WITH VERIFEYE MESSAGING, CART; PROVISC; UTRATA FORCEPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male