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 Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Eye Pain (4467)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product evaluation: the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Root cause: the product investigation could not identify a root cause for the reported complaint.Due to the exchange of a multifocal lens to a monofocal lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.No additional information has been provided at this time.There are two other complaints in this lot.There are two regulatory reports for this event.This report is for the left eye.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, a patient experienced blurred vision, especially at distance and sore eyes.The consumer stated the blurry vision was like looking through water.The doctor informed the consumer the blurred vision was caused by dry eyes, which was diagnosed prior to surgery.The consumer is currently using otc artificial tears.It was also reported she could hardly open her eyes at night and weep.While driving at night, she experienced two foot spider webs around traffic lights, halos and fluorescent light is a blur.Additional information was received indicating the iol was exchanged for another lens.There are two regulatory reports for this event.This report is for the left eye.

• 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: 12319786
• Report Number: 1119421-2021-01562
• Device Sequence Number: 19507131
• Product Code: MFK
• UDI-Device Identifier: 00380652415002
• UDI-Public: 00380652415002
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2021

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: 05/20/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U205
• Device Lot Number: 15069234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/13/2021
• 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
• Patient Age: 70 YR