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

Model Number	CNWET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Abrasion (1789); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision, glare and streaking in different lighting.Iol was exchanged for non-company lens model 28 days after the initial implant procedure.Clinical reason for explant was reported as stacking of post lasik corneal aberration with company iol aberration.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 there was no patient harm.
Additional Manufacturer Narrative
A product was not returned for analysis.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).
Additional Manufacturer Narrative
Correction provided in section h.10.Additional information provided h.3., h.6., h.11.The account indicated the use of a qualified associated cartridge and handpiece with a non-qualified viscoelastic.Information was provided that the patient had prior lasik surgery and that the issue was related to "stacking" of post lasik corneal aberrations.It was reported that no there were no product issues during or after case.Based on the information provided, the event does not appear to be related to the product.The product has not been received to evaluate.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.Additional information was provided that the company specific model with 17.5 diopter, (1.5 extended depth of focus) lens was replaced with a non-company, 17.0 diopter, company specific lens model.No additional information has been provided at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 24715431
• Report Number: 1119421-2026-00623
• Device Sequence Number: 5763162
• Product Code: POE
• UDI-Device Identifier: 00380652405195
• UDI-Public: (01)00380652405195(17)290107(11)250109(10)15969765
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: CNWET0
• Device Catalogue Number: CNWET0.175
• Device Lot Number: 15969765
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/14/2026
• Date Device Manufactured: 01/09/2025
• 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: CLAREON MONARCH IV IOL INJECTOR; MONARCH III IOL, CARTRIDGE C; OVD: ENDOCOAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female