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

Model Number	TFNT00
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Blurred Vision (2137); Diplopia/Double Vision (4802)
Date of Event	01/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned submerged in a small vial of clear solution.The lens was removed from the vial and allowed to air dry.Residue of solution and blood on one haptic tip remained on the lens.The lens was cleaned with klrp to evaluate.Both haptics were undamaged.Both haptics were pliable using surgical tweezers.The optic posterior has a medium depth small scratch located between the optic center and the optic edge.A dimensional inspection was conducted.The lens met specifications per the approved (plan view) template.A fold test was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge, handpiece, and viscoelastic.The root cause cannot be determined for the reported complaint.The explanted lens was returned.A small scratch was observed.Each lens was 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.A re-evaluation of the power and resolution was conducted and verified by engineering tech (b)(6).The lens met specification for power and optical resolution.For the portion of the complaint for "haptic did not open" the root cause cannot be determined based on the evaluation.No damage was observed to the haptics.Both haptics were easily pliable and an acceptable fold test was conducted with no abnormalities observed.Information was provided that indicated the multifocal company 15.0 diopter (add power +2.2/+3.2 diopter) was removed and replaced with a company 15.0 diopter lens.This information suggests that the replacement lens model may have been an improved selection for this patient's vision needs.Follow up attempts were made for more information.No further information has been provided.If additional information becomes available, the file will be reopened and evaluated.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported following an intraocular lens (iol) implant procedure, the patient experienced diplopia and cannot see clearly.The lens was explanted and replaced with another lens in a secondary procedure.The clinical reason for the explant was mentioned as dislocated iol and haptic did not open the right way.Additional information has been received and stated that patient had monocular diplopia and blurred vision.

• 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: 18694740
• Report Number: 1119421-2024-00271
• Device Sequence Number: 8332163
• Product Code: MFK
• UDI-Device Identifier: 00380652357630
• UDI-Public: 00380652357630
• 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: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2024

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 Expiration Date: 11/08/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.150
• Device Lot Number: 15112418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2020
• 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: MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.; ORA SYSTEM WITH VERIFEYE MESSAGING.; PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male