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	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device 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 nurse reported following the intraocular lens implantation the patient complained of significant glare, and upon examining the lens, the surgeon confirmed the presence of a scratch between the diffraction rings.The lens was explanted in a secondary procedure.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned for evaluation.The lens was returned in a plastic bag.Solution was dried on the lens.Three cut pieces of the lens were returned.This included two optic portions and a broken or cut haptic.The complete optic was not returned.A light scratch was observed near the edge of the optic on the anterior side of one of the returned pieces of the lens.Associated products were not provided.It is unknown if qualified associated products were used.The root cause for the reported glare and scratch could not be determined.We are unable to determine if this was the damage the customer was referring to or if this occurred during the lens cutting and removal.The instructions for use (ifu) instructs: company foldable iols 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.Information was provided that the company, 21.0 diopter lens was replaced with a company 21.5 diopter lens.An iol exchange for the same model with a 0.5 diopter change in power, may suggest that the replacement lens was an improved choice for the patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX 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: 17358606
• Report Number: 1119421-2023-01287
• Device Sequence Number: 6940901
• Product Code: MFK
• UDI-Device Identifier: 00380652357753
• UDI-Public: 00380652357753
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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: 09/28/2026
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.210
• Device Lot Number: 15279091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown