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	Foreign Body Sensation in Eye (1869); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	09/25/2024
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the lens does not function as designed.Before surgery, patient was explicitly advised that this lens would function as a multifocal or extended vision solution therefore he would not need glasses after implantation.Following implantation, the lenses did not function as represented.He was unable to see clearly at any distance within approximately four feet.Near and intermediate vision, which are critical for daily activities, were significantly impaired rather than improved.To address these failures, he was advised to undergo photorefractive keratectomy (prk) surgery.Prk was performed in both eyes.However, the result was not functional binocular vision.Instead, he was left with one eye primarily corrected for distance and the other for near vision.This resulted in visual imbalance and ongoing difficulty with depth perception and task focus.This outcome was not acceptable for visual needs.He was subsequently advised to undergo required posterior capsule opacification surgery and obtained two independent second opinions, both of which concluded that posterior capsule opacification surgery was not medically indicated.Despite all of these interventions, he required progressive eyeglasses or a contact lens in the left eye in addition to reading glasses.Patient visual function was worse than it was prior to surgery and remain dependent on multiple corrective aids.He worked as a systems engineer, and his profession requires sustained near and intermediate vision for tasks such as working with small circuit boards, soldering, handling small screws, assembling hardware, and building and troubleshooting technology systems.Since these procedures, performing his job has become significantly more difficult and at times impractical.This has had a direct negative impact on his ability to work effectively.The assurances provided regarding freedom from glasses were misleading, and the outcome has resulted in additional procedures, financial loss, and reduced his quality of life.Additional information has been requested but is not available at the time of this report.

• 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: 24222932
• Report Number: 9612169-2026-00210
• Device Sequence Number: 8197015
• Product Code: POE
• UDI-Device Identifier: 00380652405218
• UDI-Public: (01)00380652405218(17)280512(11)240514(10)25852756
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

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: CNWET0.185
• Device Lot Number: 25852756
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/30/2026
• Date Device Manufactured: 05/14/2024
• 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: ARTIFICIAL TEARS; FAMOTIDINE; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male