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

Model Number	TFNT00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that following implantation of an intraocular lens (iol) the close up is gone and also need reading glasses for close up which did not needed, right eye is more blurry, no nighttime vision at all and patient feels doctor gave the wrong prescription.Additional information was requested and received stating lens turning colors in my eyes and being visible and moving around in my eyes.In my right eye the implanted lens jiggles.Also there are light reflections that makes me look like a lizard in public, no night vision anymore cannot drive anymore at night only in familiar area, distance was blurry from the start.Cloudy spot that i was seeing she performed a procedure under the cuff which she put slits on my eyeball which did nothing to my vision.Lying down watching tv or just looking my vision is totally blurry, then i have to close one eye and it goes one and off clean then not.There are two medical device reports associated with this patient.This report is associated with the right 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.There have been no other complaints reported in the lot number.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: 15688748
• Report Number: 1119421-2022-02284
• Device Sequence Number: 12608799
• Product Code: MFK
• UDI-Device Identifier: 00380652357692
• UDI-Public: 00380652357692
• 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: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.180
• Device Lot Number: 15338368
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BARRETT; MONARCH II IOL CARTRIDGE B; MONARCH III IOL INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 62
• Patient Sex: Female