MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SN6AT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Headache (1880); Nausea (1970); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Dizziness (2194); Eye Irritation (4803)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, the patient experienced nausea and trapezoid vision only up close and intermediate.When the patient cover each eye independently the trapezoid flips.The patient vision was good but close vision was difficult, constant nausea at near, the eyes keep changing, the patient has dry eye, lifitegrast x 16 weeks was given for dry eyes.The possible dry eye treatment has been told possible strabismus issue.There are two medical device reports associated with this patient.This report is associated with the right eye.Additional information has been received and stated that after cataract surgeries in early (b)(6) 2024, the patient began experiencing trapezoidal distortions, with objects appearing wider at the bottom when both eyes are open and flipping depending on the eye used.Soon after, extreme nausea, dizziness, headaches, eye strain, and fatigue developed, especially with near tasks like reading, typing, or looking at screens.These symptoms, similar to what they experienced in the past with an overly strong glasses prescription, did not improve with any of the six different glasses or contact lens prescriptions tried.The patient has been treating dry eye aggressively since march, using carboxymethylcellulose eye drops initially and lifitegrast eye drops twice daily since (b)(6) 2024, with limited success.Specialists suggested causes such as mild keratoconus, residual astigmatism, and dry eye.Treatments included basic prism lenses, a computer prescription, and temporary contact lenses, which have not helped with the visual distortion or severe nausea and dizziness.Eye care providers proposed multiple options, including pilocarpine, prose lenses (not recommended after evaluation), and a potential iol exchange as a last resort.Other possible therapies include ipl treatment for dry eye and experimenting with disposable contacts for potential corneal reshaping.The patient finds some relief by looking at distant objects, but daily activities remain challenging due to persistent symptoms.For dry eye and a trial with disposable contact lenses for possible reshaping benefits.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.The product investigation could not identify a root cause for the reported complaints.The lens remains implanted.Each lens is subjected to a 100 percentage assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The reporter was the patient.The patient indicated that the trapezoid vision became evident on day three after the bilateral eye was implanted.Surgeon checked the alignment of the lens and it was accurate.No retina issues were found and vision is also very good.Patient was diagnosed with dry eye in march by another ophthalmologist.Referred to a new doctor who found very little refractive error and did not think an iol exchange was warranted.This doctor referred patient to strabismus specialist and neuro ophthalmologist.Patient indicated that their visual acuity is very good, but the nausea, dizziness and headache with near vision was becoming unbearable.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Correction information was provided in d.4.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Additional information was provided in a.2.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 20638570
• Report Number: 1119421-2024-02168
• Device Sequence Number: 7461646
• Product Code: MJP
• UDI-Device Identifier: 00380652250474
• UDI-Public: (01)00380652250474(17)271204(11)221206(10)15545743(21)15545743062
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2025

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: SN6AT4
• Device Catalogue Number: SN6AT4.225
• Device Lot Number: 15545743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 11/08/2024; 01/14/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/05/2024; 02/09/2025
• Date Device Manufactured: 12/06/2022
• 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 Age: 70 YR
• Patient Sex: Female