MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. Clareon IOL with the AutonoME Delivery System; Intraocular Lens

Model Number	CNA0T0
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implant procedure, the iol unfolded prior to insertion and was not implanted.Additional information was requested and received, stating that when injecting the iol, the surgeon reported that increased pressure and/or incorrect positioning of the introducer had made it difficult for the lens to be introduced into the eye.As a result, the lens had begun to unfold during insertion, and it was considered safer not to implant the lens.Therefore, the surgeon ruled this to be a user error and not necessarily a fault of the introducer itself.
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).

• 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 ; +1(800)757-9780
• MDR Report Key: 50191012
• Report Number: 9612169-2026-01813
• Device Sequence Number: 9915774
• Product Code: HQL
• UDI-Device Identifier: 00380652396448
• UDI-Public: (01)00380652396448(17)281015(11)251017(10)26121104
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 26121104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/10/2026
• Date Device Manufactured: 10/17/2025
• 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
• Patient Sex: Unknown