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)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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, it was noted that the leading haptic stuck underneath the lens.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo was returned.The reported complaint cannot be confirmed from the returned photo.The returned photo show company device (nozzle part only).The plunger and the lens are advanced at the mid nozzle area.Both haptics are folded on or under the optic - the exact position of haptics cannot be confirmed from the returned photo and without the evaluation of the physical product.The root cause for the reported complaint could not be determined.No sample was returned for analysis.The reported complaint cannot be confirmed from the returned photo and without the evaluation of the physical product.The company iol with the company automated pre-loaded delivery system product information document outlines several factors that could impact successful iol delivery outcomes, including: ¿qualified ophthalmic viscosurgical device (ovd) use: for optimal iol delivery, use a company qualified ovd with the company delivery system.Company has rigorously tested these products to ensure their ideal interaction with the iol and lens delivery components.Use of a non-qualified ovd or substitute product may compromise this compatibility, potentially increasing the risk of nozzle damage, iol damage, and/or other complications during use.¿prompt iol implantation: implant the iol within one (1) minute after positioning it at the pause location on the nozzle.Leaving the iol at this location for longer may increase the risk of iol folding/unfolding issues, iol damage, nozzle damage, and/or other complications during use.¿appropriate temperature: the company delivery system and company-qualified ovds should be used at operating room temperatures between 18°c (64 °f) and 23 °c (73 °f).Allow both the system and ovd to reach operating room temperature for at least 30 and 20 minutes, respectfully, before use.Colder temperatures can increase the ovd viscosity, creating greater resistance during iol delivery.Warmer temperatures may cause the iol to become excessively pliable, potentially affecting proper haptic folding and unfolding.Either of these situations can increase the risk of haptic issues, iol damage, nozzle damage, and/or other complications during use.¿sufficient ovd volume: fill the company delivery system with a company qualified ovd through the designated ovd port until ovd is observed flowing to the distal end of the nozzle tip.Insufficient ovd volume may compromise iol coverage within the nozzle lumen, increasing the risk of iol folding/unfolding issues, iol damage, nozzle damage, and/or other complications during use.Additionally, do not attempt to add ovd to the device after the lock-out assembly has been removed, or lens damage may result.To maximize iol delivery success, precise adherence to the information provided in the company iol with the company automated pre-loaded delivery system product information document is crucial.Any deviation may potentially lead to haptic issues, iol damage, nozzle damage, and/or other complications during use.Based on these investigation findings, we are unable to verify if the product contributed to the event.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: 22480642
• Report Number: 9612169-2025-01373
• Device Sequence Number: 15589613
• Product Code: HQL
• UDI-Device Identifier: 00380652397346
• UDI-Public: (01)00380652397346(17)280213(11)240215(10)25804045
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/24/2025

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: 25804045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 09/24/2025
• Date Device Manufactured: 02/15/2024
• 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