MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	CNA0T0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Intraocular Pressure Increased (1937); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following an cataract surgery with intraocular lens (iol) implant procedure, his vision was not as good as he thought it would be.His surgeon had said he would see well at a distance and would be able to drive without glasses.However, he could only see clearly up to about 10 feet, after which his vision became blurry.This was not what he had expected.Additionally, the day after surgery, he was seen at his first postoperative visit and was found to have an elevated iop (intraocular pressure) of 37¿40.The surgeon performed a pressure tap with a needle to lower the pressure.She then prescribed a steroidal anti-inflammatory eye drop to be used four times daily (qid).The steroid eye drop caused him extreme head pain, prompting him to return to the eye surgeon.At that visit, his iop had increased to 50, and the surgeon performed another needle tap to lower the pressure, bringing it down to 10.She prescribed a carbonic anhydrase inhibitor and an alpha-adrenergic agonist to be used twice daily (bid).He was seen again and was found to still have inflammation in the eye.The surgeon restarted the steroid eye drop and instructed him to use it in a weekly taper.He was afraid to use the eye drop because it had previously caused him severe headaches.The carbonic anhydrase inhibitor and alpha-adrenergic agonist caused his eye to feel lazy.
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).

• Brand Name: CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
• Common Device Name: 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: 24983759
• Report Number: 9612169-2026-00957
• Device Sequence Number: 18525420
• Product Code: HQL
• UDI-Device Identifier: 00380652393591
• UDI-Public: (01)00380652393591(17)280325(11)250327(10)26007294
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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: CNA0T0
• Device Lot Number: 26007294
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 03/27/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male