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	Macular Edema (1822); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	04/03/2025
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).
Event or Problem Description
A healthcare professional reported that following an intraocular lens (iol) implant procedure after a week of surgery, the patient complained of a decrease in visual acuity to 0.6 ¿ 0.7 and distortion of objects.The examination of the fundus also, revealed macular edema.In apr and may, the surgeon conducted 2 courses of anti-inflammatory and decongestant therapy.A positive trend was noted during the control examination.The patient's vision was recovered to 1.0 and there were no distortions of objects.Additional information received and states that patient had macular edema that complicated into dystrophy of the photoreceptor layer in favela.The patient complained of discoloration and curvature of objects.On the background of anti-inflammatory and decongestant therapy, visual acuity recovered to 0.9.However, color distortion and curvature of objects remain.At the moment, the patient cannot drive a car, hammer a nail and tighten a screw (because the curvature prevents).
Additional Manufacturer Narrative
Corrected information provided in h.6.And h.11.Correction: on initial mdr the patient event code of e0839 was missed.It should have been submitted in the initial mdr.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 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: 22541237
• Report Number: 9612169-2025-01414
• Device Sequence Number: 7001150
• Product Code: POE
• UDI-Device Identifier: 00380652405256
• UDI-Public: (01)00380652405256(17)270628(11)230630(10)25677337
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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: CNWET0.205
• Device Lot Number: 25677337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 10/03/2025
• Date Device Manufactured: 06/30/2023
• 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 Sex: Unknown