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

Model Number	CNA0T0
Medical Device Problem Codes	Failure to Fold (1255); Inaccurate Delivery (2339); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non healthcare professional reported that during an intraocular lens (iol) implant procedure, the leading haptic advanced straight in the cartridge and exited straight down and to the right and was twisted.The surgeon would exit the wound before the iol could deliver and removed the iol from the cartridge and manually loaded the iol into inserter.No patient impact or harm.Additional information has been received that lens was folded in the inserter.There was no patient impact.
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 ; 8007579780
• MDR Report Key: 21662380
• Report Number: 9612169-2025-00441
• Device Sequence Number: 15561194
• Product Code: HQL
• UDI-Device Identifier: 00380652396448
• UDI-Public: (01)00380652396448(17)270611(11)240612(10)25867004
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

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: 25867004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 03/21/2025
• Date Device Manufactured: 06/12/2024
• 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: CLAREON MONARCH IV INJECTOR; MONARCH III CARTRIDGE D; PROVISC
• Patient Age: 88 YR
• Patient Sex: Female