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

Model Number	TFNT30
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
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 healthcare professional reported that during lens implantation surgery, physician felt that the lens material was harder than usual.Had difficulty inserting into the cartridge.Procedure completed with an another lens, procedure carry on as planned.No affect on patient.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned partially inserted into the loading area of a cartridge.Viscoelastic was observed on the lens.No viscoelastic was observed in the cartridge.The cartridge had evidence that it was placed into a handpiece.The lens was removed from the cartridge and cleaned with klrp for further evaluation.The lens was foldable using folding tweezers and unfolded with no abnormalities observed.No stiffness was felt.Product history records were reviewed and the documentation indicated the product met release criteria.The account used a qualified cartridge and handpiece with a non-qualified viscoelastic.The root cause for the reported loading issues appears to be related to a failure to follow the ifu.The lens was returned partially inserted into the cartridge loading area.Viscoelastic was observed on the lens.No viscoelastic was observed in the cartridge.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The lens was evaluated and no "stiffness" was felt.It is unknown if the delivery system was being used at the recommend temperature.The ifu instructs to use the cartridge at operating room temperatures between 18° c (64° f) and 23° c (73° f).In addition, a non-qualified viscoelastic was indicated.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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received about the patient information.This file is reported for the left eye.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 17976618
• Report Number: 1119421-2023-01802
• Device Sequence Number: 2466943
• Product Code: MFK
• UDI-Device Identifier: 00380652390033
• UDI-Public: 00380652390033
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2024

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: 06/16/2026
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30.230
• Device Lot Number: 15218122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 11/20/2023; 12/14/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 12/13/2023; 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2021
• 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: HEALON GV.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Patient Sex: Unknown