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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
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 an intraocular lens (iol) implant procedure, the lens was twisted and it was defective.There was patient contact and no patient impact.Additional information has been requested.
Additional Manufacturer Narrative
The product was returned for analysis, and the reported complaint could not be observed.The intra ocular lens (iol) was not returned.The device was returned loose in a plastic bag.The lock-out assembly has been removed.Viscoelastic is observed in the device.The plunger has been advanced outside the nozzle.Stress observed on the nozzle tip.Iol was not returned.The product investigation could not identify the root cause for the reported complaint twisted and defective lens as no iol was returned.Due to this, we are unable to confirm the lens and the plunger position for advancement and determine a root cause.Damage was observed to the tip of the nozzle.The observed damage typically occurs if there is a lack of viscoelastic between the lens and the nozzle lumen and or if the plunger is not positioned correctly at the trailing optic edge for advancement.This can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the nozzle causing damage or become stuck.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 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: 22555401
• Report Number: 9612169-2025-01427
• Device Sequence Number: 9637906
• Product Code: HQL
• UDI-Device Identifier: 00380652397216
• UDI-Public: (01)00380652397216(17)271007(11)231009(10)25725726
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/30/2025

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 Model Number: CCA0T0
• Device Lot Number: 25725726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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: DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown