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

Model Number	CNA0T0
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, surgeon has used the preload device and noticed a clear band like tip of the cartridge and it was somehow shaved off and left on the tip of the cartridge.As surgeon was using preload device to implant iol, band got caught on the leading haptic and it was implanted in the eye.The surgeon described the band was being much more malleable than he would expect and it was part of the cartridge.There are two medical device reports associated with this file.This report is associated with the 2 of 3 files.Additional information has been requested.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.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.
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The product was not returned for analysis.Only an empty sample container was received.While the physical product and the reported "clear band like the tip of the cartridge" was not returned for evaluation in this case, similar complaints have been reported where the product was returned, and laboratory analysis identified the foreign material as nozzle coating.The coating material in question possesses biocompatible properties.In the reported cases, the material was removed, and the iol (intraocular lens) remained implanted without further issue.No process changes or material modifications were found in the coating line review, and nozzle processing showed no issues.An nci was initiated as part of this investigation.Precise adherence to the directions for use sections in the preloaded device automated pre-loaded delivery system product is critical for optimal iol delivery, avoiding potential damage to the iol, device or nozzle.The below identifies several factors that, individually or combined, could potentially contribute to an outcome similar to the reported event.These factors include, but are not limited to: improper ovd (ophthalmic viscosurgical device) use: if inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly and cause delivery issues and /or damage.Use of a non-qualified viscoelastic.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to underfill, overfill, misfolding, delivery issues and /or damage.Incorrect ovd temperature: if the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement and cause delivery issues and / or product damage.Excessive dwell time: delay in implantation after lens positioning.As referenced in the ifu (instructions for use) (section: precautions), ¿once the lens is in position at the pause location on the nozzle, the lens should be implanted within 1 minute.¿ extended delay may impact lens behavior and delivery performance.Based on the results from the product history record, the products met release criteria.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.

• 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: 22469885
• Report Number: 9612169-2025-01364
• Device Sequence Number: 4234533
• Product Code: HQL
• UDI-Device Identifier: 00380652393669
• UDI-Public: (01)00380652393669(17)271120(11)241121(10)25947594
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 25947594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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
• Patient Sex: Unknown