MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWET3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Insufficient Information (4580); Posterior Capsule Opacification (4807)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A non health care professional reported that, following the intraocular lens (iol) implant procedure, the iol has been explanted in a secondary procedure with unknown issues.Additional information has been requested however no further information received.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.The reporter states the company lens 26 d iol was replaced with a company lens 28 d lens.An iol exchange for a difference equal to or greater than two diopters indicates the event is most likely related to a calculation error.Based on the information provided, the event does not appear to be related to the product.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated, the patient experienced poor quality vision and subjective visual disturbance, which were impacting activities of daily living.Two week post operation, the patient complains of strained vision in the distance more noticeable if eyes are dry.Continued prednisolone and ketorolac as directed.Three weeks post operation, the patient complains of strained and blurry vision while driving.The patient states no improvement in strain with artificial tears.The patient had myopic shift, and continued prednisolone and ketorolac as directed, refraction m (unspecified) for driving (temporary).Discussed possible lasik enhancement in future.Eleven weeks post operation, the patient complains of difficulty with distance vision and intermediate vision.The patient thinks possible slight improvement with distance since having punctal plugs and using artificial tears.On (b)(6) 2024 the patient referred for evaluation of lasic/ photorefractive keratectomy (prk), post cataract surgery the patient complains of blurred vision in distance and near.The patient had posterior capsular opacification (pco).The patient was not satisfied with overall vision after surgery.Ha had myopic outcome.On (b)(6) 2025 discussed risks, benefits, and alternatives of prk.Explained bcva was still around 20/30.Discussed alternative was iol exchange would be an option with left eye for distance vision.On (b)(6) 2025 the patient had iol exchange.The patient symptoms were resolved status post iol exchange.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
Additional information was provided in a.3.B., b.2., b.3., b.5., b.6., b.7., e.1.And h.6.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 21984288
• Report Number: 9612169-2025-01003
• Device Sequence Number: 20952316
• Product Code: MJP
• UDI-Device Identifier: 00380652455404
• UDI-Public: (01)00380652455404(17)261023(11)221025(10)25496863
• 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
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2025

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: CCWET3
• Device Catalogue Number: CCWET3.260
• Device Lot Number: 25496863
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 06/06/2025; 07/04/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 07/01/2025; 07/29/2025
• Date Device Manufactured: 10/25/2022
• 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: CLAREON TORIC UV ABSORBING IOL.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown