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	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, lens was implanted successfully but the crack on the blue plunger.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.Photo review: provided photo shows what appears to be a blue plunger of an company device.The plunger appears to be fully advanced outside the nozzle tip.There appears to be a crack on the nozzle tip.The reported "crack on the blue plunger" cannot be determined from the provided photo.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.11.The product was not returned for analysis.A photo was returned, damage was observed to the nozzle tip in the retuned photo.Provided photo shows what appears to be a blue plunger of a company device.The plunger appears to be fully advanced outside the nozzle tip.There appears to be a crack on the nozzle tip.The reported "crack on the blue plunger" cannot be determined from the provided photo.We are unable to determine the root cause for the reported complaint "crack on the blue plunger".The returned photo show damage to the nozzle tip, this could be interpreted as the reported "crack on the blue plunger".The dfu instructs to inspect the company device nozzle before use, inspect device nozzle for damage, particulates, or deformation.Ensure that device is completely intact and that the plunger and lock-out assembly have not been moved.If the device does not pass the inspection criteria, use another company intraocular lens (iol) and company delivery system.All company devices are 100% cosmetically inspected as per approved manufacturing procedures and the observed damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify that the damage was present when opened and if the device 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: 23485865
• Report Number: 9612169-2025-02222
• Device Sequence Number: 21389390
• Product Code: HQL
• UDI-Device Identifier: 00380652397261
• UDI-Public: (01)00380652397261(17)290619(11)250621(10)26051696
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: 26051696
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2025
• 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