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

Model Number	TFNT00
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that during surgery, they noticed that the lens was blocked in injector despite the usual protocol and the viscous put.Lens was not implanted, no patient impact.They took back-up lens, implanted without issue.Additional information has been requested.
Additional Manufacturer Narrative
A sample device was 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).
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens is pressed against two posts in the lens case.One haptic is pointing down into a drain hole in the lens case.The lens is pressed against a post in the lens case with the haptic optic junction.This has caused the haptic to bent up and twist.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported issue of the lens stuck in the injector.The lens was returned in the lens case and not the cartridge.The cartridge was not returned for evaluation.Associated products were not provided.It is unknown if qualified products were used.Company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a 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.Follow up attempts were made.At this point, no further information available at this time.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: 17976710
• Report Number: 1119421-2023-01804
• Device Sequence Number: 14344620
• Product Code: MFK
• UDI-Device Identifier: 00380652357807
• UDI-Public: 00380652357807
• Combination Product (Y/N): N
• Initial Reporter Country: NC
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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 Expiration Date: 07/14/2026
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.235
• Device Lot Number: 15233087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2021
• 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
• Patient Sex: Unknown