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

Model Number	TFAT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	07/26/2024
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 facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision.The iol was exchanged for another lens 1 month following the initial procedure.Clinical reason for the explant was mentioned as mechanical complication.
Event or Problem Description
There are two medical device reports associated with this file.This report is associated with the left eye.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.Correction information b.5., b.7.The lens was returned inside a plastic specimen cup with a screw top lid.Viscoelastic was dried on the lens.No damage was observed.The lens was cleaned with klrp to further evaluate.After removal of the dried viscoelastic, there was no lens damage observed.A dimensional (plan view) inspection was conducted.The lens was within specifications per the approved template.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge, handpiece, and viscoelastic combination.The root cause cannot be determined for the reported complaint of blurred vision, explant.Each lens is subjected to a 100 percent 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 was retested.The lens met specification for power and resolution for a company 10.0 diopter lens.Additional information was provided that, in the surgeon opinion, a quality issue with the lens did not cause or contribute to the event.The multifocal company 10.0 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non-company 10.0 diopter lens.Due to the exchange of a multifocal 10.0 diopter lens to an extended depth of focus 10.0 diopter lens, this suggests that the design difference from a multifocal company lens to an extended depth of focus lens for the replacement lens may have been an improved choice for the patient vision needs.File will be reopened when new information or the product is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX UV ABSORBING 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; 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: 20914187
• Report Number: 1119421-2024-02463
• Device Sequence Number: 12878307
• Product Code: MFK
• UDI-Device Identifier: 00380652429511
• UDI-Public: (01)00380652429511(17)250630(11)200701(10)15078162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: 06/30/2025
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.100
• Device Lot Number: 15078162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 03/21/2025
• Date Device Manufactured: 07/01/2020
• 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 D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; RAO200E 10.0
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female