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

Model Number	TFNT00
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health professional reported that during an intraocular lens (iol) implant surgery, there was a coating of the lens.The lens did come into contact with the patient.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned cut into three pieces in a vial of liquid.A "film" was not observed.A qualified cartridge was indicated.No other associated products were provided.It is unknown if qualified products were used.The root cause for the reported complaint could not be determined.It is unclear what was meant by the report of "coating of the lens occurred".No film was observed on the three returned iol pieces.Clarification for the reported event has not been provided by the reporter.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
• MDR Report Key: 11855257
• Report Number: 1119421-2021-01068
• Device Sequence Number: 19087972
• Product Code: MFK
• UDI-Device Identifier: 00380652357715
• UDI-Public: 00380652357715
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 03/09/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.190
• Device Lot Number: 15049985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D