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); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
After implantation of an intraocular lens (iol), a customer complained of dry eyes.The customer had tear duct plugs placed multiple times and utilized the prescribed eye drops, but the condition didn't get any better.After applying a placenta patch and afterwards a laser to reduce scar tissue, the consumer once more employed the advised eye drops.Even prescription readers, prescription distance lenses, and trifocal spectacles were utilized by consumer.All of these were helpful, but they didn't solve every issue.For example, some of the letters were faded and occasionally weren't dark enough to be seen on the page.Nothing in a picture was apparent to the consumer when looked at it.Large lighted circles and lines around all lights were among the other issues that consumer observed.This was mostly an issue when driving throughout the day or more so at night because it made it difficult to see when other cars were around.As a result, consumer stopped driving at night.Because the consumer had difficulties with depth perception, moving around was problematic, glare was an issue, and switching from light to dark was challenging.To perceive an object, the consumer has to look straight at it.The poor definition made it difficult to look at pictures.According to the consumer, the doctor advised to wear contacts for a day then lasik to modify the prescription.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product investigation could not identify a root cause for the reported complaint.Implant (b)(6) 2020.The second opinion doctor stated the patient had astigmatism.The consumer was under impression that the lenses corrected for astigmatism.Was given a new prescription for glasses.The company, 19.0 diopter lens does not correct for astigmatism.No further information has been provided at this time.File will be reopened when new information is received.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
• 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: 17314319
• Report Number: 1119421-2023-01248
• Device Sequence Number: 3957378
• Product Code: MFK
• UDI-Device Identifier: 00380652414975
• UDI-Public: 00380652414975
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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: 08/31/2024
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U190
• Device Lot Number: 12743114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown