MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWET4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.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.
Event or Problem Description
A physician reported that following an intraocular lens (iol) implantation procedure, the patient began experienced hazy vision in left eye (os) was greater than od (right eye) so, the patient underwent post prk (photorefractive keratectomy).Additionally, the patient also experiencing blurry vision at distance and near, hazy vision, residual astigmatism, halos and glare resulting in an inability to drive at night.The patient was advised to continue using preservative-free artificial tears (lubricating eye drops) 3 to 4 times daily.Additionally, a tapering regimen of a corticosteroid was initiated, with instructions to instill one drop in the left eye (os) three times a day for 2 weeks.Additional information was requested.There are two related reports for this patient.This report addresses the patient's left eye and another manufacturer report will be filed for the fellow eye.

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22095786
• Report Number: 1119421-2025-01518
• Device Sequence Number: 8022661
• Product Code: MJP
• UDI-Device Identifier: 00380652466783
• UDI-Public: (01)00380652466783(17)260724(11)220726(10)15456138
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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 Expiration Date: 07/24/2026
• Device Model Number: CNWET4
• Device Lot Number: 15456138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/28/2025
• Date Device Manufactured: 07/26/2022
• 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: ATS (ARTIFICIAL TEARS).; LOTEMAX.; OFLOXACIN.; PRED FORTE.; PROLENSE.; VEVYE.; WAVELIGHT EX500 EXCIMER LASER.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown