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	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
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-healthcare professional reported that during an intraocular lens (iol) implant procedure, the preloaded device malfunctioned.The surgery was completed with replacement lens.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo was returned.Reported complaint was observed on the returned photo.Photo review: the returned photo shows an company device.The plunger is advanced to nozzle entry and is bent.The iol (intraocular lens) cannot be observed.Based on our observation of the attached photo, the plunger is bent.As the product was not returned for analysis, definitive determination of the reported complaint cannot be made, however, the most likely cause for the observed severely bent plunger is a lens that became stuck in the device, preventing the plunger from advancing continuously outside of the nozzle tip.Continuous force on the lever to push the plunger, while being blocked by the stuck lens, likely caused the plunger to bend under the force.Lens may become stuck in the device: if inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to become ¿stuck¿ in the device due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds (ophthalmic viscosurgical device) may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent, and this may inhibit lens advancement.Any of the above listed causes alone, or in combination, may cause the lens to become stuck.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(6).

• 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: 24469980
• Report Number: 9612169-2026-00447
• Device Sequence Number: 9581737
• Product Code: HQL
• UDI-Device Identifier: 00380652397360
• UDI-Public: (01)00380652397360(17)290922(11)250924(10)26111233
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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: 26111233
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 06/01/2026
• Date Device Manufactured: 09/24/2025
• 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: Female