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

Model Number	TFNT00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non health care professional reported that during an intraocular lens (iol) implant procedure, the customer returned lens with a report it had a scratch on it.Additional information has been requested.This report is associated with multiple complaints.This file is 2 of 2.
Event or Problem Description
Additional information received and stated that the scrub nurse pushed the plunger beyond the lens, it was decided that the lens was likely damaged as on retracting the plunger, lens was likely damaged as on retracting the plunger, it was slightly grainy on the lens in pulling it posteriorly in the injector.This report is associated with multiple complaints.This file is 2 of 2.
Additional Manufacturer Narrative
Additional information was provided in a.1., a.2., a.3a., b.3., b.5., d.3., h.3., h.6.And h.11.The lens was not returned.Only the lens carton an label set were returned.Complaint and product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified associated products were used.The root cause for the reported scratch could not be determined.The instruction for use instructs: company foldable intraocular lens are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Due diligence has been performed in an attempt to obtain further information on this event.The facility has not responded to requests for follow-up information.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: ACRYSOF IQ PANOPTIX 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: 21402138
• Report Number: 1119421-2025-00407
• Device Sequence Number: 8317066
• Product Code: MFK
• UDI-Device Identifier: 00380652357814
• UDI-Public: (01)00380652357814(17)280131(11)230202(10)15578035
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.240
• Device Lot Number: 15578035
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/10/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Female