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

Model Number	CCA0T0
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A non-health care professional reported that during the intraocular lens (iol) implant procedure lens came out crooked.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in b.5.And h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that reporter noticed, lens was crooked upon priming and there was no patient contact.
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo was returned.The reported complaint cannot be confirmed from the returned photo.Received photo shows the upper part of a nozzle.The plunger is fully advanced outside of the device.One haptic is observed, it is protruding from the nozzle tip.The remaining intraocular lens (iol) cannot be observed.We cannot confirm the reported "lens came out crooked" based on the returned photos and without the evaluation of the physical product.The reported complaint cannot be confirmed from the provided photos.Not enough information was received to complete a thorough investigation.A definitive determination of the reported complaint cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that reporter noticed, lens was crooked upon priming and there was no patient contact.

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL WITH 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: 24268513
• Report Number: 9612169-2026-00245
• Device Sequence Number: 10022022
• Product Code: HQL
• UDI-Device Identifier: 00380652397285
• UDI-Public: (01)00380652397285(17)291022(11)251024(10)26144001
• Combination Product (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 04/24/2026

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: CCA0T0
• Device Lot Number: 26144001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 02/21/2026; 04/01/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/16/2026; 04/24/2026
• Date Device Manufactured: 10/24/2025
• 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