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	Vitreous Floaters (1866); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	01/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non health care professional reported that following the cataract surgery with intraocular lens (iol) implant procedure it has taken rather a long time to adjust to my new visual system.It is rather poor for looking at power point in a classroom and looking at the tv.Unfortunately the patient now feel short sighted.The patient had really struggled with other distances.One of these would be at 6 m which is used for assessment of visual acuity.The optometrist informs patient had a -1 diopter cylindrical error in both eyes and modest spherical errors of between 0.5 and 1.0 diopter.I have also been told that this would not be improved by top up refractive surgery to the cornea.Additional information received and stated that, vision seriously degraded after lens implantation.Serious loss of contrast sensitivity with loss of ability to drive during the day with adverse visibility conditions.Inability to work in certain conditions of low contrast with non-image light entering the eye creating glare during daylight.Double vision in some circumstances (vertical white posts, edges of white cars, led signs).Exacerbation of pre-existing symptom of floaters.

• 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: 17727536
• Report Number: 1119421-2023-01579
• Device Sequence Number: 6399739
• Product Code: MFK
• UDI-Device Identifier: 00380652357753
• UDI-Public: 00380652357753
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2023

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: 12/31/2022
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.210
• Device Lot Number: 12590179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2018
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 81 KG