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

Model Number	TFNT40
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that, after intraocular lens implantation surgery, the patient experienced poor vision.Hence the lens was explanted and replaced with another lens in a secondary procedure.The clinical reason for explant was other mechanical complications of lens, pigment on lens.Additional information was received stating that, there was patient harm.The diagnosis of the harm was corneal edema secondary to lens exchange.In the surgeon's opinion, the prognosis is suspected visual improvement once corneal edema subsides.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned in a specimen cup.Blood and solution was dried on the lens.The optic was cut into pieces, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.The lens was cleaned with klotho-related protein klrp (klrp) for further evaluation.No "pigment" on the lens was observed.It is possible the dried solution or blood may have been interpreted as the reported "pigment on the lens" complaint.Complaint and product history records were reviewed and documentation indicated the product met release criteria.A qualified associated cartridge and handpiece was indicated.The viscoelastic indicated is not qualified for the product combination used.The product investigation could not identify a root cause for the reported complaint.Power and resolution testing could not be conducted due to the extensive optic damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Information was provided that the multifocal toric 20.5 diopter (+2.25cyl) add power +2.2 & 3.2 lens model was replaced with a monofocal non-toric non-company 19.5 diopter lens.Due to the exchange of a multifocal toric lens to a monofocal non-toric lens, may suggest that the replacement lens model was an improved choice for the patient's vision needs.The reported "pigment on the lens" complaint was not observed.The lens was cleaned with klrp for further evaluation.No "pigment" was observed.It is possible the dried solution or blood may have been interpreted as the reported complaint.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: 18836136
• Report Number: 1119421-2024-00412
• Device Sequence Number: 7227039
• Product Code: MFK
• UDI-Device Identifier: 00380652416061
• UDI-Public: 00380652416061
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40U205
• Device Lot Number: 12738999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IMPLANTATION/FOLDING FORCEPS USED: CURVED TIES.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; REPLACEMENT IOL L161AL 19.5SN (B)(6).; VISCOELASTIC : OCUCOAT LOT 030391 EXP: 07/2026.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown