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

Model Number	CNA0T0
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Failure to Advance (2524)
Health Effect - Clinical Codes	Corneal Edema (1791); Eye Injury (1845); Blurred Vision (2137); Eye Pain (4467)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that during the intraocular lens (iol) implant procedure, the surgeon said that there was something wrong with the injector.He had to cut to get the injector out and use another lens to complete the surgery.The patient experienced lot of pain during and after the procedure.The patient also had suture.The patient vision was still blurry and slowly healing.The patient was under treatment the steroids.The patient had lupus and it got flared up.Additional information has been requested.
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).
Additional Manufacturer Narrative
Additional information provided in b.2., b.5., b.6., b.7., d.1., d.2., d.4., d.10., e.4.And h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received that when lens was injected the trailing haptic was stuck to the injecting device and was unable to be separated.Upon attempt to removal of haptic there was temporal iris damage and prolapse.Surgeon removed the lens by cutting the cornea and placed same model lens in the bag and suture to cornea.The patient had corneal edema and iris tids.The light sensitivity was improved but not completely resolved.Corneal edema has resolved.Permanent tids, vision likely to improve with artificial tears due to dry eye and with glasses.

• 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: 23907933
• Report Number: 9612169-2025-02615
• Device Sequence Number: 18440217
• Product Code: HQL
• UDI-Device Identifier: 00380652393775
• UDI-Public: (01)00380652393775(17)280712(11)250714(10)26067874
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 26067874
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/30/2026
• Date Device Manufactured: 07/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female