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

Model Number	TFNT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.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 physician reported that following a cataract extraction with an intraocular lens (iol) implant procedure, there was no specific refraction issue.The patient's visual acuity was poor.The physician suggested to watch the patient's progress, but the replacement surgery was proceeded because the patient's status was not improved.Additional information was requested.
Additional Manufacturer Narrative
Product evaluation: the lens was returned for evaluation.Solution is dried on the lens.The lens has been cut into four pieces, typical of insertion and removal from the eye.Scratches and marks are observed on the lens.A power and resolution test could not be performed due to extensive damage to the lens.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause for the reported events could not be determined.A malfunction has not been indicated or information provided that the lens was the cause of the event.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was provided that the iol was exchanged for the same model iol but a difference of 1d power.Had this information been received earlier, this event would not have been reported.

• 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: 11870783
• Report Number: 1119421-2021-01082
• Device Sequence Number: 19637209
• Product Code: MFK
• UDI-Device Identifier: 00380652357623
• UDI-Public: 00380652357623
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: 10/31/2024
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.145
• Device Lot Number: 12757304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention