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	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, lens was explanted at secondary procedure due to patient could not adapt.The procedure was completed on the same day with unspecified non company lens.There was no patient harm.Additional information was requested.
Additional Manufacturer Narrative
The lens was returned in a noncompany lens holder inside a small opened noncompany pouch.Viscoelastic was dried on the lens.The optic was broken (cut) into pieces.The lens was cleaned with klrp to further evaluate.No additional damage was observed.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge and qualified handpiece.A non-qualified viscoelastic was indicated.The root cause cannot be determined for the reported complaint.The explanted lens was cut into pieces, typical of an insertion and removal.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 was provided from the account that the patient could not adapt to the iol(intraocular lens).The account stated the root cause for this event was unknown.The multifocal tfat00 18.5 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non-company 18.5 diopter lens.Due to the exchange of a multifocal 18.5 diopter lens to a non-company extended depth of focus lens of the same diopter, this suggests that an extended depth of focus replacement lens may have been an improved choice for the patient's vision needs.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received stating lens was replaced with other company same diopter lens.
Additional Manufacturer Narrative
Additional information was provided in b.5.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: 21549251
• Report Number: 1119421-2025-00631
• Device Sequence Number: 18186479
• Product Code: MFK
• UDI-Device Identifier: 00380652429689
• UDI-Public: (01)00380652429689(17)261119(11)211121(10)15308048
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/21/2025

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 Model Number: TFAT00
• Device Catalogue Number: TFAT00.185
• Device Lot Number: 15308048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/21/2025
• Date Device Manufactured: 11/21/2021
• 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; VISCOELASTIC USED: HEALON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown