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 Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Eye Irritation (4803)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, due to light reflections, she couldn't see anything.When she mentioned the situation to physician, she was told there's nothing wrong, everything was normal.About 20-30 days later, it was said that the lens was surrounded by the eye membrane and was cleaned.After one month, she persistently mentioned that she couldn't see, and the discomfort persisted.It was stated that there was a displacement, and the lens was put back in place, but her vision started deteriorating every day.She has been mentally exhausted.When she went for a check-up with a blurry vision and a feeling of having water inside, she was told everything was normal; however, there was no improvement in her vision, and the problem continued to worsen.In third month, she went to another doctor.It was stated that there was a deviation in the prescription, and the wrong prescription company lens was implanted.She couldn't determine whether it's company or the doctor who was at fault.Additional information has been requested, received and stated that the consumer advised that there had been a prescription error while trying to correct sliding lens.She will have an examiner laser operation in coming days.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested, received and stated that there was a prescription shift, which was tolerated with excimer laser.However, the lens displacement still persisted because there was a halo-shaped reflection on the side, causing a lot of discomfort.Additional information has been requested, received and stated that there seems to be a crescent-shaped reflection in patient eye.This happened after the membrane covering the lens was cleaned.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product remained implanted.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The reporter was the patient.New information was provided that the issues were only with the right eye.At this time, the patient is reporting one issue."in my right eye, there seems to be a crescent-shaped reflection.This happened after the membrane covering the lens was cleaned".Patient feels lens is displaced.File will be reopened if 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: 18638994
• Report Number: 1119421-2024-00195
• Device Sequence Number: 12694114
• Product Code: MFK
• UDI-Device Identifier: 00380652357784
• UDI-Public: 00380652357784
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.225
• Device Lot Number: 15540784
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 02/20/2024; 03/21/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 03/19/2024; 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female