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

Model Number	TFAT00
Medical Device Problem Codes	Failure to Advance (2524); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during a cataract extraction with an intraocular lens (iol) implant procedure, while injecting lens into patient¿s eye, lens was stuck onto the middle of the plunger which scratched the lens.There was patient contact observed.Procedure was completed on the same day.Additional information was received stating there was no patient harm reported.
Additional Manufacturer Narrative
The product was not returned.A carton with an empty lens case and packaging inserts were returned.There is no damage observed to the lens case or the locking arm mechanism.The lens case functions as intended.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause.The product was not returned for evaluation.Information was provided that in the surgeons opinion, the product did not cause or contribute to the event.There have been no other complaints reported in the lot number.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; 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: 16884210
• Report Number: 1119421-2023-00850
• Device Sequence Number: 6174162
• Product Code: MFK
• UDI-Device Identifier: 00380652429726
• UDI-Public: 00380652429726
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2023

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: 03/05/2025
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.205
• Device Lot Number: 15038106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/08/2023
• Date Device Manufactured: 03/06/2020
• 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, CARTRIDGE C; MONARCH, INJECTOR, UNSPECIFIED; VISCOAT
• Patient Sex: Unknown