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 Deliver (2338); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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).
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens implant procedure the lens would not advance into eye through incision.Scrub tech loaded lens into company injector and had issues with it deploying.There was a patient contact and procedure was completed.Additional information has been received and stated that leading haptic on lens was twisted and this made the lens stick while entering the incision.Lens was removed and reloaded, manually, but the issue persisted, and the surgeon was unable to get it completely in the eye.The procedure was completed on the same day.There was no patient harm.

• 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: 22114278
• Report Number: 9612169-2025-01155
• Device Sequence Number: 4171638
• Product Code: HQL
• UDI-Device Identifier: 00380652396493
• UDI-Public: (01)00380652396493(17)260716(11)230718(10)25676341
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 05/30/2025

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: 07/16/2026
• Device Model Number: CNA0T0
• Device Lot Number: 25676341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/30/2025
• Date Device Manufactured: 07/18/2023
• 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: ANGLED MCPHEARSON FORCEPS; DISCOVISC OVD; MONARCH III IOL , CARTRIDGE D; MONARCH III IOL , INJECTOR; PROVISC OVD
• Patient Age: 59 YR
• Patient Sex: Female