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

Model Number	TFNT50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Diplopia/Double Vision (4802)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following intraocular lens (iol) implant procedure, the patient still see quadruple from the eye and patient sees 2 letters very clear one next to the other (not overlapped) when looks at a letter and another 2 letters more soft or transparent overlapped.The patient was consulted with physician and physician was done unspecified examinations with unspecified machines and gave a device to place a unspecified drop 2 times a week.Additional information has been received that healthcare professional reported that the patient was not able to read and could not see properly.The doctor gave pilocarpine drops.The tests that performed were normal but the refraction was increased and decided not to give drops.The doctor suggested the patient to use power contact lens which was helpful.The patient wants refraction stability.
Additional Manufacturer Narrative
This report originally filed as 9612169-2023-00638.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).
Additional Manufacturer Narrative
The product was not returned.Complaint history and product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause for the reported complaint.The product was not returned.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.Information was provide that the patient had difficulty with near vision.Patient was placed on pilocarpine 0.16% drops and upon post op follow-up vision was 20/25 and j1.Patient was happy and continued with drops.On (b)(6) 2023 follow up indicated vision was 20/25 and j2.Follow up on (b)(6) 2023 patient complained of visual issue, no longer using drops.Patient was provide with a +2.00 contact lens which appeared to help the issue.Patient to be followed for stability.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 18525256
• Report Number: 1119421-2024-00115
• Device Sequence Number: 15048808
• Product Code: MFK
• UDI-Device Identifier: 00380652416597
• UDI-Public: 00380652416597
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: TFNT50
• Device Catalogue Number: TFNT50U205
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: LENSX LASER SYSTEM; ORA SYSTEM WITH VERIFEYE MESSAGING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male