MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. 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	Blurred Vision (2137); Visual Impairment (2138); Posterior Capsule Opacification (4807)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.The root cause for the reported complaint could not be determined.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that, after intraocular lens implantation surgery, the patient does not correct her vision with optical aids and visual acuity (va) ranges on 0.7.The doctor attempted to improve va with a pinhole refraction, but this did not improve vision either.Since the patient's satisfaction could not be improved, all types of studies were performed, such as cvc, oct, and electroretinography.In addition to a complete routine ophthalmological examination, no possible cause was found.The doctor also performed a capsulotomy, but it only corrected 0.7 in both eyes.The patient, however, continues to report discomfort.When the doctor looked for uncorrected residual vision with fogging, there was no improvement (which could indicate being very close to emmetropia).Physician also complained that the patient has a slight increase in the blind spot, but autofluorescence and electroretinography were normal.At first, she had difficulty adapting in both eyes but reached 0.9 visual acuity.Then it worsened to 0.7 (decimal).She reads 0.75 with both eyes.The visual acuity is generally not bad, but the patient reports discomfort.Additional information has been received and stated that the patient is not satisfied with the result, and the doctor is trying to align her expectations.Patient remains angry and dissatisfied.The patient's visual acuity, numerically speaking, isn't too bad at any distance, but it's not what she expected.Patient is not satisfied, and the doctor is addressing issues of expectations and even the possibility of explantation and replacement with another iol.Patient was found having slight residual myopia.Physician was also suspected for opacities in the capsule, hence performed a yag laser to clear it and make it transparent.There was no significant change.Physician also planned for next step, in case the iol is not in the correct position, is an anterior chamber oct or a ubm (to confirm if there is axial displacement or tilt).There are two medical reports associated with this patient.This file belongs to right eye.

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23754311
• Report Number: 9612169-2025-02463
• Device Sequence Number: 21228367
• Product Code: POE
• UDI-Device Identifier: 00380652405263
• UDI-Public: (01)00380652405263(17)280429(11)240501(10)25845226
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

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: CNWET0
• Device Catalogue Number: CNWET0.210
• Device Lot Number: 25845226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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: CONSTELLATION HANDPIECE; OPTICAL AIDS
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown