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

Model Number	TFNT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Halo (2227)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.Additional information was requested and received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure the patient unable to tolerate the halos.The iol was exchanged in a secondary procedure.Additional information was requested.
Additional Manufacturer Narrative
Additional information provided in h.3, h.6 and h10 the product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.Information was provided that the 1.50cyl, 17.0 diopter (add power +2.2/+3.2) was replaced with an 1.50cyl, 20.5 diopter lens.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

• 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
• MDR Report Key: 11927654
• Report Number: 1119421-2021-01153
• Device Sequence Number: 4356706
• Product Code: MFK
• UDI-Device Identifier: 00380652415460
• UDI-Public: 00380652415460
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2025
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30U170
• Device Lot Number: 15066728
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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: ACRYSOF IQ IOL; MONARCH III CARTRIDGE D; PROVISC; ACRYSOF IQ IOL; MONARCH III CARTRIDGE D; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR