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

Model Number	CNA0T0
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that during an cleaning and sterilization of intraocular lens (iol) implant procedure, iol became stuck in the cartridge, causing the haptic to break.The procedure was completed with another iol.There was no patient contact and no patient harm.
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
The product was not returned for analysis.Only photo was returned.Plunger underride was observed on the returned photo.Photo review: the attached photo shows an activated company device.The plunger is advanced outside of the nozzle tip and appears to be advanced under the iol(intraocular lens).The iol appears to be advanced into the nozzle entry.The complainant indicates the use of non company viscoelastic, which is not qualified for use with the associated product, this is not a qualified company product combination.Based on our observations of the returned photo, the plunger is extended beyond the nozzle tip and appears to be advanced under the lens.According to the information provided by the customer, the most likely root cause is failure to follow ifu(instructions for use), as the customer states the use of a non-qualified viscoelastic.The use of an unqualified ovd (ophthalmic viscosurgical device) may cause damage to the lens and potential complications during the implantation process.Based on the results from the product history record, the products met release criteria.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: 21604300
• Report Number: 9612169-2025-00381
• Device Sequence Number: 4527664
• Product Code: HQL
• UDI-Device Identifier: 00380652393591
• UDI-Public: (01)00380652393591(17)260422(11)230424(10)25629712
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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 Expiration Date: 04/22/2026
• Device Model Number: CNA0T0
• Device Lot Number: 25629712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 06/02/2025
• Date Device Manufactured: 04/24/2023
• 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: VISCOPROTECTOR COGEVISC®.
• Patient Sex: Unknown