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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non health care professional reported that during surgery they have noticed that the trailing haptic present posteriorly upon injection today.He was able to get it to release.No patient impact/harm was reported.Additional information has been requested.
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).
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., and h.11.The product was returned for analysis and the reported complaint could not be confirmed.Video demonstrating the reported event was also returned.The device was returned in an opened blister tray inside the product carton.The lock-out assembly has been removed.Viscoelastic is observed in the device.The plunger has been fully advanced outside the nozzle.No damage observed.No iol (intraocular lens) returned.Video provided shows an implanted iol.One haptic appears to be folded on the posterior optic surface.The surgeon uses a surgical tool to guide it from the optic.The root cause for the reported complaint could not be determined.While the investigation did not identify a manufacturing issue, the company iol pre-loaded delivery system product information document outlines several factors that could impact successful iol delivery outcomes, including: qualified ovd use: for optimal iol delivery, use an company qualified ovd with the 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: company delivery system and company-qualified ovds should be used at operating room temperatures between 18 degree c (64 degree f) and 23 degree c (73 degree f).Allow both the system and ovd (ophthalmic viscosurgical device) 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 an 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: 21737355
• Report Number: 9612169-2025-00499
• Device Sequence Number: 3955790
• Product Code: HQL
• UDI-Device Identifier: 00380652397391
• UDI-Public: (01)00380652397391(17)271209(11)231211(10)25766795
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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: 25766795
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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: PROVISC
• Patient Age: 72 YR
• Patient Sex: Unknown