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

Model Number	TFNT00
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that the lens was faulty.Additional information was requested.
Additional Manufacturer Narrative
The lens was returned, in a non-company peel pouch.Solution was dried on the lens.One haptic was broken/torn from the haptic/optic junction area (not returned).The optic was torn/split/cracked from the haptic/optic junction area towards the center of the optic.Associated products were not provided.It is unknown, if qualified products were used.The root cause could not be determined, for the reported complaint of ¿faulty¿.The specific lens issue was not specified.Damage to the lens was observed.While we are unable to determine, the root cause of the lens damage, our observation reasonably suggests that it is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely, related to customer handling.Company foldable iols are qualified, for use with an company qualified delivery system (handpiece and cartridge), and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications, during the implantation process.Follow up attempts were made.No further information has been provided 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: 15740863
• Report Number: 1119421-2022-02362
• Device Sequence Number: 12353336
• Product Code: MFK
• UDI-Device Identifier: 00380652357838
• UDI-Public: 00380652357838
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 04/04/2023

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 Model Number: TFNT00
• Device Catalogue Number: TFNT00.250
• Device Lot Number: 15347058
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 11/05/2022
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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