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

Model Number	TFNT40
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the empty lens carton was returned with the packaging inserts.The lens, lens case, and peel pouch were not returned for evaluation.Product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified associated products were used.The root cause could not be determined for the reported complaint.The iol was not returned for an evaluation.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported via reply card with a description of cracked intraocular lens (iol) by technician during loading which was noted after insertion into the 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: 16938689
• Report Number: 1119421-2023-00905
• Device Sequence Number: 20676309
• Product Code: MFK
• UDI-Device Identifier: 00380652390576
• UDI-Public: 00380652390576
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/16/2023

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: 08/30/2025
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40.225
• Device Lot Number: 15096642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/16/2023
• Date Device Manufactured: 08/31/2020
• 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
• Patient Age: 70 YR
• Patient Sex: Male